Seragen Diagnostics, Inc.
Medical device manufacturer in Indianapolis, IN.
20510(k) clearances
0PMA approvals
0recalls
Device types
- GKL Counter, Cell, Automated (Particle Counter) 2
- JJT Enzyme Controls (Assayed And Unassayed) 2
- DHR System, Test, Rheumatoid Factor 1
- LJC Enzyme Linked Immunoabsorbent Assay… 1
- JPK Mixture, Hematology Quality Control 1
- JIW Calibrator, Surrogate 1
- CEX Chromatographic Separation, Lactate… 1
- JGS Electrode, Ion Specific, Sodium 1
- LLL Extractable Antinuclear Antibody, Antigen… 1
- LKJ Antinuclear Antibody, Antigen, Control 1
- CKG Radioimmunoassay, Acth 1
- CFM Bathophenanthroline, Colorimetry, Iron… 1
- GIF Diluent, Blood Cell 1
- CDQ Urease And Glutamic Dehydrogenase, Urea… 1
- CJE Nitrophenylphosphate, Alkaline Phosphatase… 1
- CGA Glucose Oxidase, Glucose 1
- JMO Ferrozine (Colorimetric) Iron Binding… 1
- GRP Antisera, All Types, H. Influenza 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K872148 | Vivid Chlamydia(Tm)LJC · Traditional | 08/19/1987SE |
| K851663 | Quick-Count Hematology ControlsJPK · Traditional | 07/23/1985SE |
| K852260 | Quick-Chem Calibration SetJIW · Traditional | 07/22/1985SE |
| K851520 | Ck/Ld Isoenzymes Controls(Human)JJT · Traditional | 06/25/1985SE |
| K851521 | LD-1(IMMUNO) Separation SetCEX · Traditional | 05/10/1985SE |
| K850209 | Quick-LyteJGS · Traditional | 02/27/1985SE |
| K844743 | Seratest Ena(Rnp/Sm) DeterminationLLL · Traditional | 02/04/1985SE |
| K842563 | Seratest DNA DeterminationLKJ · Traditional | 10/25/1984SE |
| K841504 | Quick-Count Plus 2GKL · Traditional | 06/11/1984SE |
| K840793 | Ck/Mb Immuno-Isoenzyme Control SerumJJT · Traditional | 04/13/1984SE |
| K840863 | Seratest RF Latex DeterminationDHR · Traditional | 04/04/1984SE |
| K834396 | Direct Iron Reagent SetCFM · Traditional | 02/21/1984SE |
| K833972 | Quick-Count Hematology Reagent KitGIF · Traditional | 02/17/1984SE |
| K833971 | Quick-CountGKL · Traditional | 01/30/1984SE |
| K833931 | Urea Nitrogen-UvCDQ · Traditional | 01/13/1984SE |
| K833744 | Alkaline Phosphatase-RateCJE · Traditional | 01/13/1984SE |
| K832926 | Enzymatic Glucose DeterminationCGA · Traditional | 10/28/1983SE |
| K832759 | Total Iron-Binding Capacity AccesoryJMO · Traditional | 10/14/1983SE |
| K831525 | H-Flu B Elisa TestGRP · Traditional | 09/29/1983SE |
| K822115 | Seragan ACTH125 I-Ria KitCKG · Traditional | 10/18/1982SE |