Icl Scientific
Medical device manufacturer in Fountain Valley, CA.
48510(k) clearances
0PMA approvals
0recalls
Device types
- DEW Igg, Antigen, Antiserum, Control 4
- JJW Urinalysis Controls (Assayed And Unassayed) 3
- CZP Iga, Antigen, Antiserum, Control 2
- DEH Lambda, Antigen, Antiserum, Control 2
- DFH Kappa, Antigen, Antiserum, Control 2
- DIF Drug Mixture Control Materials 2
- DFT Igm, Antigen, Antiserum, Control 2
- DAK Complement C1q, Antigen, Antiserum, Control 2
- DHC System, Test, Systemic Lupus Erythematosus 2
- DEX Alpha-1-B-Glycoprotein, Antigen, Antiserum… 1
- JJY Multi-Analyte Controls, All Kinds (Assayed) 1
- GTQ Antistreptolysin - Titer/Streptolysin O… 1
- KTP Complement C3b Activator Immunoassay Reagents 1
- DEM Alpha-1-Antitrypsin, Antigen, Antiserum… 1
- DDB Ceruloplasmin, Antigen, Antiserum, Control 1
- DCK C-Reactive Protein, Antigen, Antiserum, And… 1
- DBA Complement C1 Inhibitor (Inactivator)… 1
- JZH Factor B, Antigen, Antiserum, Control 1
- DFC Lipoprotein, Low-Density, Antigen… 1
- JBQ Antithrombin Iii Quantitation 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K883942 | Hycor Sentry Drugs of Abuse Urine ControlJJY · Traditional | 11/10/1988SE |
| K843565 | Kova Trol I,Ii, III Human Urine-DriedJJW · Traditional | 10/05/1984SE |
| K833761 | Therapeutic Drug ControlDKB · Traditional | 01/13/1984SE |
| K832823 | Enzymune-Test TSHJLW · Traditional | 10/14/1983SE |
| K831383 | Event-Test SlideJHJ · Traditional | 06/22/1983SE |
| K823199 | Enzyme-Test DigoxinKXT · Traditional | 11/29/1982SE |
| K822777 | Therapeutic Drug ControlDIF · Traditional | 10/08/1982SE |
| K822346 | Histimune Enzyme-Ana TestLJM · Traditional | 10/08/1982SE |
| K822465 | Enzymune System IJJE · Traditional | 09/14/1982SE |
| K821374 | Enzymune-Test InsulinCFP · Traditional | 05/28/1982SE |
| K821097 | Systemic Lupus Erythermatosus Anti-N-Dna · Traditional | 05/05/1982SE |
| K821000 | Enzymune-Test DigoxinDON · Traditional | 04/26/1982SE |
| K820879 | Enzyme-Test TBC T4 UptakeKHQ · Traditional | 04/16/1982SE |
| K820763 | Enzym-Linked T3CDP · Traditional | 04/15/1982SE |
| K820750 | Enzymune-Test T4KLI · Traditional | 04/06/1982SE |
| K811756 | Therapeutic Drug ControlDIF · Traditional | 07/15/1981SE |
| K811219 | Kova Strip 6JIR · Traditional | 05/21/1981SE |
| K811126 | Aim System (for Igg)DEW · Traditional | 05/08/1981SE |
| K811125 | Aim System (for Iga)CZP · Traditional | 05/08/1981SE |
| K811124 | Aim System (for Igm)DFT · Traditional | 05/08/1981SE |
| K810917 | Kova Trol I Human Urine (Dried)JJW · Traditional | 04/14/1981SE |
| K810226 | Sle Anti-N-Dna Latex TestDHC · Traditional | 02/09/1981SE |
| K810056 | Immunology Control SerumDEW · Traditional | 02/09/1981SE |
| K803274 | Automated Immunoprecipitin Method/IgaCZP · Traditional | 01/26/1981SE |
| K803272 | Automated Immunoprecipitin Method/IcgDFZ · Traditional | 01/26/1981SE |
| K803251 | Aip System-Method for IgmDFT · Traditional | 01/26/1981SE |
| K800897 | Rid System-Quad Multitest Igg, Iga,Etc.DEW · Traditional | 05/08/1980SE |
| K792472 | Electro-Immuno-Quantitation (Eiq)DAK · Traditional | 12/27/1979SE |
| K792314 | Rid Systems - ALPH-1-ACID GlycoproteinFAM · Traditional | 12/06/1979SE |
| K791824 | Antiserum to Human ImmunoglobulinsDEW · Traditional | 10/17/1979SE |
| K790831 | Antistreptolysin (Aso) Latex Slide TestGTQ · Traditional | 06/15/1979SE |
| K790257 | Systemic LupusDHC · Traditional | 03/15/1979SE |
| K790059 | Proactivator C3, C4 and C3KTP · Traditional | 03/15/1979SE |
| K781408 | Rid System-(Acp) TestDEM · Traditional | 08/21/1978SE |
| K781024 | Ceruoplasmin Serum Anti-HumanDDB · Traditional | 08/14/1978SE |
| K781023 | ALPHA-1-ACID Glycoprotein Serum, Anti-HuDEX · Traditional | 08/14/1978SE |
| K781022 | Anti-Human Ciq SerumDAK · Traditional | 08/14/1978SE |
| K781017 | Anti-Human C1 Inhibitor Serum (Goat)DBA · Traditional | 08/14/1978SE |
| K781016 | C3PA (GBG) Properdin Factor BJZH · Traditional | 08/14/1978SE |
| K781015 | Anti-Human LDL SerumDFC · Traditional | 08/14/1978SE |
| K781026 | Antithrombin III Serum, Anti-HumanJBQ · Traditional | 08/10/1978SE |
| K781220 | Anti-Human Lambda SerumDEH · Traditional | 07/27/1978SE |
| K781028 | Kappa Serum (Free & Bound) Anti-HumanDFH · Traditional | 07/27/1978SE |
| K781027 | Kappa Serum (Free) Anti-HumanDFH · Traditional | 07/27/1978SE |
| K781025 | Lambda Serum (Free) Anti-HumanDEH · Traditional | 07/27/1978SE |
| K780482 | Kova Trol IIIJJW · Traditional | 05/03/1978SE |
| K780325 | Rid System-Human C-Reactive ProteinDEN · Traditional | 03/17/1978SE |
| K760354 | Test, Slide for C-Reative ProteinDCK · Traditional | 08/11/1976SE |