Company ยท US
Seragen Diagnostics, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1982 to 1987. Name variants (Inc, Corp, punctuation) are merged.
20510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GKL | Counter, Cell, Automated (Particle Counter) | 2 |
| JJT | Enzyme Controls (Assayed And Unassayed) | 2 |
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 1 |
| CEX | Chromatographic Separation, Lactate Dehydrogenase Isoenzymes | 1 |
| CFM | Bathophenanthroline, Colorimetry, Iron (Non-Heme) | 1 |
| CGA | Glucose Oxidase, Glucose | 1 |
| CJE | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | 1 |
| CKG | Radioimmunoassay, Acth | 1 |
| DHR | System, Test, Rheumatoid Factor | 1 |
| GIF | Diluent, Blood Cell | 1 |
| GRP | Antisera, All Types, H. Influenza | 1 |
| JGS | Electrode, Ion Specific, Sodium | 1 |
| JIW | Calibrator, Surrogate | 1 |
| JMO | Ferrozine (Colorimetric) Iron Binding Capacity | 1 |
| JPK | Mixture, Hematology Quality Control | 1 |
| LJC | Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group) | 1 |
| LKJ | Antinuclear Antibody, Antigen, Control | 1 |
| LLL | Extractable Antinuclear Antibody, Antigen And Control | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 19, 1987 | K872148 | VIVID CHLAMYDIA(TM) Seragen Diagnostics, Inc. | LJC |
| Jul 23, 1985 | K851663 | QUICK-COUNT HEMATOLOGY CONTROLS Seragen Diagnostics, Inc. | JPK |
| Jul 22, 1985 | K852260 | QUICK-CHEM CALIBRATION SET Seragen Diagnostics, Inc. | JIW |
| Jun 25, 1985 | K851520 | CK/LD ISOENZYMES CONTROLS(HUMAN) Seragen Diagnostics, Inc. | JJT |
| May 10, 1985 | K851521 | LD-1(IMMUNO) SEPARATION SET Seragen Diagnostics, Inc. | CEX |
| Feb 27, 1985 | K850209 | QUICK-LYTE Seragen Diagnostics, Inc. | JGS |
| Feb 4, 1985 | K844743 | SERATEST ENA(RNP/SM) DETERMINATION Seragen Diagnostics, Inc. | LLL |
| Oct 25, 1984 | K842563 | SERATEST DNA DETERMINATION Seragen Diagnostics, Inc. | LKJ |
| Jun 11, 1984 | K841504 | QUICK-COUNT PLUS 2 Seragen Diagnostics, Inc. | GKL |
| Apr 13, 1984 | K840793 | CK/MB IMMUNO-ISOENZYME CONTROL SERUM Seragen Diagnostics, Inc. | JJT |
| Apr 4, 1984 | K840863 | SERATEST RF LATEX DETERMINATION Seragen Diagnostics, Inc. | DHR |
| Feb 21, 1984 | K834396 | DIRECT IRON REAGENT SET Seragen Diagnostics, Inc. | CFM |
| Feb 17, 1984 | K833972 | QUICK-COUNT HEMATOLOGY REAGENT KIT Seragen Diagnostics, Inc. | GIF |
| Jan 30, 1984 | K833971 | QUICK-COUNT Seragen Diagnostics, Inc. | GKL |
| Jan 13, 1984 | K833931 | UREA NITROGEN-UV Seragen Diagnostics, Inc. | CDQ |
| Jan 13, 1984 | K833744 | ALKALINE PHOSPHATASE-RATE Seragen Diagnostics, Inc. | CJE |
| Oct 28, 1983 | K832926 | ENZYMATIC GLUCOSE DETERMINATION Seragen Diagnostics, Inc. | CGA |
| Oct 14, 1983 | K832759 | TOTAL IRON-BINDING CAPACITY ACCESORY Seragen Diagnostics, Inc. | JMO |
| Sep 29, 1983 | K831525 | H-FLU B ELISA TEST Seragen Diagnostics, Inc. | GRP |
| Oct 18, 1982 | K822115 | SERAGAN ACTH125 I-RIA KIT Seragen Diagnostics, Inc. | CKG |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||