Company ยท US
Serono-Baker Diagnostics, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1988 to 1992. Name variants (Inc, Corp, punctuation) are merged.
23510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CHP | Radioimmunoassay, Estradiol | 4 |
| CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone | 2 |
| CGR | Radioimmunoassay, Cortisol | 2 |
| DBF | Ferritin, Antigen, Antiserum, Control | 2 |
| JLS | Radioimmunoassay, Progesterone | 2 |
| CDP | Radioimmunoassay, Total Triiodothyronine | 1 |
| CEC | Radioimmunoassay, Free Thyroxine | 1 |
| CEP | Radioimmunoassay, Luteinizing Hormone | 1 |
| CFT | Radioimmunoassay, Prolactin (Lactogen) | 1 |
| CGJ | Radioimmunoassay, Follicle-Stimulating Hormone | 1 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 1 |
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 1 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 1 |
| KHQ | Radioassay, Triiodothyronine Uptake | 1 |
| KLI | Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine | 1 |
| KXT | Enzyme Immunoassay, Digoxin | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 30, 1992 | K924257 | TESTOSTERONE SEROZYME(TM) ENZYME IMMUNOASSAY Serono-Baker Diagnostics, Inc. | CDZ |
| Mar 2, 1992 | K915164 | SRI TESTOSTERONE ENZYME IMMUNOASSAY Serono-Baker Diagnostics, Inc. | CDZ |
| Mar 2, 1992 | K914886 | SRI(TM) CORTISOL ENZYME IMMUNOASSAY(MAG SOL PHASE) Serono-Baker Diagnostics, Inc. | CGR |
| Jan 17, 1992 | K915602 | SRI DIGOXIN ENZYME IMMUNOASSAY Serono-Baker Diagnostics, Inc. | KXT |
| Nov 19, 1991 | K912937 | SR1 FREE T4 ENZYME IMMUNOASSAY Serono-Baker Diagnostics, Inc. | CEC |
| Oct 23, 1991 | K914462 | SRI PROGESTERONE ENZYME IMMUNOASSAY(MAG SOLD PHAS) Serono-Baker Diagnostics, Inc. | JLS |
| Sep 18, 1991 | K911912 | SR1 T3 UPTAKE ENZYME IMMUNOASSAY(MAG SOLID-PHASE) Serono-Baker Diagnostics, Inc. | KHQ |
| Aug 16, 1991 | K911217 | SR1 T4 ENZYME IMMUNOASSAY (MAGNETIC SOLID-PHASE) Serono-Baker Diagnostics, Inc. | KLI |
| Jul 25, 1991 | K912318 | ESTRADIOL SEROZYME ENZYME IMMUNO (MAG SOLID-PHASE) Serono-Baker Diagnostics, Inc. | CHP |
| May 28, 1991 | K911396 | SR1 ESTRADIOL ENZYME IMMUNOASSAY Serono-Baker Diagnostics, Inc. | CHP |
| May 24, 1991 | K910837 | SRI TSH IMMUNENZYMETRIC ASSAY Serono-Baker Diagnostics, Inc. | JLW |
| May 1, 1991 | K910737 | SRI T3 IMMOENZYMETRIC ASSAY Serono-Baker Diagnostics, Inc. | CDP |
| Apr 5, 1991 | K911175 | SRI FERRITIN IMMOENZYMETRIC ASSAY(MAG SOLID-PHASE) Serono-Baker Diagnostics, Inc. | DBF |
| Jan 23, 1991 | K903975 | SEROZYME CORTISOL TEST KIT Serono-Baker Diagnostics, Inc. | CGR |
| Dec 27, 1989 | K896145 | ESTRADIOL SEROZYME IMMUNOENZYMETRIC ASSAY Serono-Baker Diagnostics, Inc. | CHP |
| Dec 19, 1989 | K894175 | SRI HUMAN CHORIONIC GONADOTROPIN IMMUNOENZ ASSAY Serono-Baker Diagnostics, Inc. | JHI |
| Oct 17, 1989 | K895380 | SR1 PROLACTIN (PRL IMMUNOENZYMETRIC ASSAY Serono-Baker Diagnostics, Inc. | CFT |
| Jun 20, 1989 | K893605 | SRI LUTEINIZING HORMONE IMMUNOENZYMETRIC ASSAY Serono-Baker Diagnostics, Inc. | CEP |
| Jun 9, 1989 | K892706 | SR1 (FSH) IMMUNOENZYMETRIC ASSAY Serono-Baker Diagnostics, Inc. | CGJ |
| Mar 8, 1989 | K890645 | ESTRADIOL MAIACLONE RADIOIMMUNOASSAY KIT Serono-Baker Diagnostics, Inc. | CHP |
| Feb 2, 1989 | K884794 | PROGESTERONE SEROZYME IMMUNOENZYMETRIC ASSAY Serono-Baker Diagnostics, Inc. | JLS |
| Dec 27, 1988 | K884683 | FERRITIN SEROZYME IMMUNOENZYMETRIC ASSAY Serono-Baker Diagnostics, Inc. | DBF |
| Oct 31, 1988 | K883539 | SR1 SYSTEM AUTOMATED PHOTOMETRIC ANALYZER Serono-Baker Diagnostics, Inc. | JJE |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||