Emd Chemicals, Inc.
Medical device manufacturer in Gibbstown, NJ.
62510(k) clearances
0PMA approvals
7recalls
Device types
- CHH Enzymatic Esterase--Oxidase, Cholesterol 5
- CDQ Urease And Glutamic Dehydrogenase, Urea… 4
- JIS Calibrator, Primary 4
- CGS Nad Reduction/Nadh Oxidation, Cpk Or… 3
- JQB Kinetic Method, Gamma-Glutamyl Transpeptidase 3
- CFR Hexokinase, Glucose 3
- LFR Glucose Dehydrogenase, Glucose 3
- JIT Calibrator, Secondary 3
- GMQ Antigens, Nontreponemal, All 2
- JJE Analyzer, Chemistry (Photometric… 2
- DNN Calibrators, Ethyl Alcohol 2
- IAF Wright'S Stain 2
- CEO Phosphomolybdate (Colorimetric), Inorganic… 2
- CDO Acid, Uric, Uricase (U.V.) 2
- CEK Biuret (Colorimetric), Total Protein 2
- JPZ Colorimetric Method, Gamma-Glutamyl… 1
- GNA Antisera, All Types, Escherichia Coli 1
- CIT Nadh Oxidation/Nad Reduction, Ast/Sgot 1
- CFJ Nad Reduction/Nadh Oxidation, Lactate… 1
- CIG Diazo Colorimetry, Bilirubin 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K031367 | Duopath Verotoxins Glisa TestGNA · Traditional | 01/23/2004SE |
| K990516 | Ethyl Alcohol Clinical Standard SolutionsDNN · Traditional | 03/31/1999SE |
| K981926 | Ethyl Alcohol Clinical Standard SolutionsDLJ · Traditional | 07/22/1998SE |
| K973054 | Ethyl Alcohol Clinical Standard SolutionsDNN · Traditional | 10/01/1997SE |
| K951494 | Amylase Test Item 97381/94 (R1, 97382/94 (R2-SR)CIJ · Traditional | 12/11/1995SE |
| K951750 | Glucose Test Item Number 97375/94LFR · Traditional | 09/06/1995SE |
| K950234 | Total Protein Test (Tpro) Item Number: XXXXX/R1. R2CEK · Traditional | 06/14/1995SE |
| K950128 | Total Protein Test (Tpro) Item XXXXX/R1. R2CEK · Traditional | 05/15/1995SE |
| K945322 | Phosphorus Test (Phos) Item Number 65416CEO · Traditional | 12/07/1994SE |
| K945368 | Phosphorus Test (Phos)CEO · Traditional | 12/02/1994SE |
| K840883 | Unipak 100 Analyzer, 65156 & ChemistrJJE · Traditional | 05/16/1984SE |
| K840477 | Unitized Hematology Set 65132/93GIF · Traditional | 03/05/1984SE |
| K834294 | Eltrachem Diatrac Glycosylated HemoglobLCP · Traditional | 01/24/1984SE |
| K833448 | Epos Chemistry Analyzer 5060 & 6410JJE · Traditional | 12/22/1983SE |
| K833017 | Serum Iron & TIBC#65084 & 65085JIY · Traditional | 11/03/1983SE |
| K832480 | Trust RPR Titration Card Test #65145GMQ · Traditional | 09/12/1983SE |
| K832479 | Trust RPR Card Test #65144GMQ · Traditional | 09/12/1983SE |
| K831027 | Extrelut Qe Extraction ColumnsKEA · Traditional | 05/16/1983SE |
| K831200 | Immunohematological Saline #97139JCE · Traditional | 05/09/1983SE |
| K830832 | Rheumatoid Factor-Rapid Card Test #65114DHR · Traditional | 04/18/1983SE |
| K830241 | Ultra Chem Bun-Uv #65080-65081CDQ · Traditional | 04/05/1983SE |
| K830239 | Ultra Chem Enzymatic Cholesterol OxidaCHH · Traditional | 04/05/1983SE |
| K830309 | Ultra Chem Enzymatic Cholesterol OxidaseCHH · Traditional | 02/28/1983SE |
| K830308 | Ultra Zyme Plus Gamma GT #65055 & 56JQB · Traditional | 02/28/1983SE |
| K830240 | Ultrazyme Plus Gamma Gt-Mca #65055-65056JQB · Traditional | 02/18/1983SE |
| K830238 | Ultra Chem Cresolcaversachem #65082CIC · Traditional | 02/18/1983SE |
| K823883 | Ultrazyme Plus Gamma-Gt, #64959/65032JQB · Traditional | 01/28/1983SE |
| K823300 | Bun-Un Centrifichum 500, #65080/81CDQ · Traditional | 01/09/1983SE |
| K823472 | Ultra Chem Ban-Uv #65080 & 65081CDQ · Traditional | 12/28/1982SE |
| K823402 | Ultrachem Bun-Uv-Gem Saec APPLI.#65080&CDQ · Traditional | 12/26/1982SE |
| K823354 | Ultrachem Enzymatic Cholesterol OxidaseCHH · Traditional | 12/22/1982SE |
| K822937 | Glucose/Urea Nitrogen StandardJIX · Traditional | 11/05/1982SE |
| K822982 | Midas 100 Hemacolor Stain #66030HYB · Traditional | 10/27/1982SE |
| K822981 | Midas 1000 Wright Giemsa Stain #66020IAF · Traditional | 10/27/1982SE |
| K822980 | Midas 1000 Wright Stain #66010IAF · Traditional | 10/27/1982SE |
| K822477 | Creatinine Standard #65072JIS · Traditional | 09/17/1982SE |
| K822473 | Calcium Standard, Item #65075JIS · Traditional | 09/17/1982SE |
| K822479 | Bilirubin Calibrator #65071JIT · Traditional | 09/14/1982SE |
| K822478 | Albumin Standard, #65070JIT · Traditional | 09/14/1982SE |
| K822476 | Phosphorous Standard #65073JIS · Traditional | 09/14/1982SE |
| K822475 | Total Protein Standard, #65074JIT · Traditional | 09/14/1982SE |
| K822474 | Cholesterol Standard #65077JIS · Traditional | 09/14/1982SE |
| K822418 | Ultrachem Enzymatic Chol. OxidaseCHH · Traditional | 09/14/1982SE |
| K821475 | Ultrachem E-Glu #64976&65040CFR · Traditional | 06/25/1982SE |
| K821474 | Ultrachem Uric Acid Aidh #65047CDO · Traditional | 06/03/1982SE |
| K821473 | Ultrazyme Plus Cki, #64978,65027&65028CGS · Traditional | 06/03/1982SE |
| K821472 | Ultrachem Crea #64972 · Traditional | 06/03/1982SE |
| K821471 | Ultrazyme Plus Alp #64962,65029&65030CJE · Traditional | 06/02/1982SE |
| K821470 | Ultrachem E-Glu #64976 & 65040CFR · Traditional | 06/02/1982SE |
| K821469 | Ultrachem Gluc-Dh, #65048LFR · Traditional | 06/02/1982SE |
| K821468 | Ultrazyme Plus-Gt, #64959 & 65032JPZ · Traditional | 06/02/1982SE |
| K821465 | Ultrachem Uric Acid Aidh, #65047CDO · Traditional | 06/02/1982SE |
| K821464 | Cardiozyme Plus Ck-Mb, #65045CGS · Traditional | 06/02/1982SE |
| K821463 | Ultrachem Gluc-Dh, #65048LFR · Traditional | 06/02/1982SE |
| K821461 | Ultrachem E-Glu, #64976 & 65040CFR · Traditional | 06/02/1982SE |
| K821561 | Versachem AnalyzerJJQ · Traditional | 06/01/1982SE |
| K821467 | Ultrazyme Plus Got, #64953,65033&65034CIT · Traditional | 06/01/1982SE |
| K821466 | Ultrazyme Plus LDH, #64950,65038&65039CFJ · Traditional | 06/01/1982SE |
| K821462 | Ultrachem T-Bili, #64971CIG · Traditional | 06/01/1982SE |
| K821460 | Ultrazyme Plus Ck-I, #64978,65027&65028CGS · Traditional | 06/01/1982SE |
| K821441 | Enzymatic Cholesteral Oxidase #650550CHH · Traditional | 06/01/1982SE |
| K821459 | Ultrazyme Plus Amyl #65031&64982JFJ · Traditional | 05/28/1982SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0043-2012 | Harleco Giemsa Stain 25 gram glass bottle, Item #228-12 Manufactured for EMD Chemicals…Stains may yield lower then expected absorbance levels resulting in under stained hematology specimens. | 04/04/2011Terminated |
| Z-2303-2008 | Histochemical PAS (Periodic Acid Schiff) Reaction Set' Class I, IVD; Set of 4 bottles…Two complaints that kit was not performing properly with positive controls. | 06/02/2008Terminated |
| Z-1607-2008 | EMD Chemicals, Harleco Brand Ethanol Standard, 1.0 mg/ml; 1.0 mg Ethanol in 1 ml, 10…Incorrect concentration: 2 ampules measuring 2.0 mg/ml were found in a lot of 20 ampules of 1.0 mg/ml… | 03/27/2008Terminated |
| Z-0133-2008 | Harleco May and Grunwald's Stain; 0.17% w/v; Methanol Solution UN1230; EMD Chemicals…Out of Spec -- The Batch (Lot) was incorrectly released after being rejected for out of specification of… | 07/30/2007Terminated |
| Z-0499-2007 | Anaerotest;Microbiology , 50 test strips 1.15112 Store dry and tightly closed. Store at…Lot # OC553145 of Anaerotest failed to remain in specification. QC indicator shows an anaerobic environment… | 08/17/2006Terminated |
| Z-0498-2007 | Anaerotest for microbiology Specification: Performance Test Anerobic: white within 4-6…Lot # OC553145 of Anaerotest failed to remain in specification. QC indicator shows an anaerobic environment… | 08/17/2006Terminated |
| Z-0305-2007 | Histochemical PAS (Periodic Acid Schiff) Reaction Set. in vitro diagnostic. Product size…Due to loose caps, the SO2 levels dropped significantly from release levels causing the product not to… | 07/25/2006Terminated |