Dade Intl., Inc.
Medical device manufacturer in Miami, FL.
30510(k) clearances
1PMA approvals
0recalls
Device types
- JJX Single (Specified) Analyte Controls… 2
- JWY Manual Antimicrobial Susceptibility Test… 2
- JIT Calibrator, Secondary 2
- MMI Immunoassay Method, Troponin Subunit 2
- DKB Calibrators, Drug Mixture 1
- CKA Nadh Oxidation/Nad Reduction, Alt/Sgpt 1
- GJS Test, Time, Prothrombin 1
- CEM Electrode, Ion Specific, Potassium 1
- CDT Lipase Hydrolysis/Glycerol Kinase Enzyme… 1
- DDR Myoglobin, Antigen, Antiserum, Control 1
- GKP Instrument, Coagulation, Automated 1
- JIF Enzymatic Method, Ammonia 1
- LDP Colorimetry, Acetaminophen 1
- JHS Differential Rate Kinetic Method, Cpk Or… 1
- LEH Radioimmunoassay, Vancomycin 1
- KLT Enzyme Immunoassay, Carbamazepine 1
- LCD Enzyme Immunoassay, Gentamicin 1
- LCR Fluorescent Immunoassay, Tobramycin 1
- LTT Panels, Test, Susceptibility, Antimicrobial 1
- CEC Radioimmunoassay, Free Thyroxine 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K974343 | Dade InnovinGJS · Traditional | 07/22/1998SE |
| K970505 | Dade PFA-100 Platelet Function Analyzer/Pfa Collagen/Epinephrine Test Cartridge/Pfa…JOZ · Traditional | 11/17/1997SE |
| K973974 | Dade Tru-Liquid Cardiac ControlJJT · Traditional | 11/06/1997SE |
| K973668 | Cardiac Troponin-I (Trop) CalibratorJIT · Traditional | 10/20/1997SE |
| K972524 | Dried Gram-Positive Mic/Combo PanelsJWY · Traditional | 09/08/1997SE |
| K972782 | Dade Stratus Ck-Mb Fluorometric Enzyme ImmunoassayJHX · Traditional | 08/15/1997SE |
| K972287 | Dade Tru-Liquid Bilirubin ControlJJX · Traditional | 07/07/1997SE |
| K964660 | Paramax Cholesterol ReagentCHH · Traditional | 06/04/1997SE |
| K970676 | Dried Gram-Negative Mic/Combo PanelsJWY · Traditional | 05/02/1997SE |
| K964715 | Paramax Salicylate ReagentDKJ · Traditional | 04/25/1997SE |
| K970330 | Dade Indirect Imt System with TCO2 ElectrodeCEM · Traditional | 04/14/1997SE |
| K964346 | Paramax Triglycerid ReagentCDT · Traditional | 03/28/1997SE |
| K965213 | Stratus Myoglobin Gluorometric Enzyme ImmunoassayDDR · Traditional | 02/10/1997SE |
| K964862 | Troponin-I Test SystemMMI · Traditional | 02/10/1997SE |
| K964139 | Sysmex CA-6000GKP · Traditional | 02/06/1997SE |
| K964565 | Paramax Ammonia and Ammonia Blank ReagentJIF · Traditional | 11/22/1996SE |
| K963244 | Acetaminophen Flex Reagent CartridgeLDP · Traditional | 09/23/1996SE |
| K962817 | Drug Calibrator IIDKB · Traditional | 09/16/1996SE |
| K963267 | Vancomycin Flex Reagent CartridgeLEH · Traditional | 09/13/1996SE |
| K962820 | Carbamazepine Flex Reagent CartridgeKLT · Traditional | 09/13/1996SE |
| K962819 | Gentamicin Flex Reagent CartridgeLCD · Traditional | 09/13/1996SE |
| K962818 | Tobramycin Flex Reagent CartridgeLCR · Traditional | 09/13/1996SE |
| K962150 | Dried Gram-Negative and Gram-Positive Mic/Combo PanelsLTT · Traditional | 08/16/1996SE |
| K962602 | Aca Plus Free THYROXINE(FT4) MethodCEC · Traditional | 08/15/1996SE |
| K962594 | Aca Plus FT4 CalibratorJIT · Traditional | 08/15/1996SE |
| K960103 | Dade Moni-Trol Candidate Product CombinationsJIX · Traditional | 04/26/1996SE |
| K952250 | Stratus Ck-Mb Dendrimer Fluorometric Enzyme Immunoassay & Stratus Ck-Mb Dendrimer High…JHS · Traditional | 07/17/1995SE |
| K951890 | Stratus Cardiac Troponin-I Fluorometric Enzyme Immunmnoassay & Stratus Cardiac…MMI · Traditional | 07/13/1995SE |
| K951888 | Dade Stratus Troponin-I ControlJJX · Traditional | 07/13/1995SE |
| K951332 | Paramax Alanine Aminotransferase (GPT) ReagentCKA · Traditional | 06/19/1995SE |
PMA approvals
- P870049 Microscan Rapid Panels · 02/24/1988 · 27 supplements