Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Serono-Baker Diagnostics, Inc. — Predicate Candidate Screening
23 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
69 daysmedian FDA review time
148 days90th percentile
23clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K924257 | TESTOSTERONE SEROZYME(TM) ENZYME IMMUNOASSAY | Serono-Baker Diagnostics, Inc. | 1992-11-30 | 98 | 0 |
| K915164 | SRI TESTOSTERONE ENZYME IMMUNOASSAY | Serono-Baker Diagnostics, Inc. | 1992-03-02 | 109 | 0 |
| K914886 | SRI(TM) CORTISOL ENZYME IMMUNOASSAY(MAG SOL PHASE) | Serono-Baker Diagnostics, Inc. | 1992-03-02 | 124 | 0 |
| K915602 | SRI DIGOXIN ENZYME IMMUNOASSAY | Serono-Baker Diagnostics, Inc. | 1992-01-17 | 35 | 0 |
| K912937 | SR1 FREE T4 ENZYME IMMUNOASSAY | Serono-Baker Diagnostics, Inc. | 1991-11-19 | 137 | 0 |
| K914462 | SRI PROGESTERONE ENZYME IMMUNOASSAY(MAG SOLD PHAS) | Serono-Baker Diagnostics, Inc. | 1991-10-23 | 16 | 0 |
| K911912 | SR1 T3 UPTAKE ENZYME IMMUNOASSAY(MAG SOLID-PHASE) | Serono-Baker Diagnostics, Inc. | 1991-09-18 | 141 | 0 |
| K911217 | SR1 T4 ENZYME IMMUNOASSAY (MAGNETIC SOLID-PHASE) | Serono-Baker Diagnostics, Inc. | 1991-08-16 | 150 | 0 |
| K912318 | ESTRADIOL SEROZYME ENZYME IMMUNO (MAG SOLID-PHASE) | Serono-Baker Diagnostics, Inc. | 1991-07-25 | 62 | 0 |
| K911396 | SR1 ESTRADIOL ENZYME IMMUNOASSAY | Serono-Baker Diagnostics, Inc. | 1991-05-28 | 60 | 0 |
| K910837 | SRI TSH IMMUNENZYMETRIC ASSAY | Serono-Baker Diagnostics, Inc. | 1991-05-24 | 86 | 0 |
| K910737 | SRI T3 IMMOENZYMETRIC ASSAY | Serono-Baker Diagnostics, Inc. | 1991-05-01 | 69 | 0 |
| K911175 | SRI FERRITIN IMMOENZYMETRIC ASSAY(MAG SOLID-PHASE) | Serono-Baker Diagnostics, Inc. | 1991-04-05 | 18 | 0 |
| K903975 | SEROZYME CORTISOL TEST KIT | Serono-Baker Diagnostics, Inc. | 1991-01-23 | 148 | 0 |
| K896145 | ESTRADIOL SEROZYME IMMUNOENZYMETRIC ASSAY | Serono-Baker Diagnostics, Inc. | 1989-12-27 | 65 | 0 |
| K894175 | SRI HUMAN CHORIONIC GONADOTROPIN IMMUNOENZ ASSAY | Serono-Baker Diagnostics, Inc. | 1989-12-19 | 187 | 0 |
| K895380 | SR1 PROLACTIN (PRL IMMUNOENZYMETRIC ASSAY | Serono-Baker Diagnostics, Inc. | 1989-10-17 | 48 | 0 |
| K893605 | SRI LUTEINIZING HORMONE IMMUNOENZYMETRIC ASSAY | Serono-Baker Diagnostics, Inc. | 1989-06-20 | 41 | 0 |
| K892706 | SR1 (FSH) IMMUNOENZYMETRIC ASSAY | Serono-Baker Diagnostics, Inc. | 1989-06-09 | 56 | 0 |
| K890645 | ESTRADIOL MAIACLONE RADIOIMMUNOASSAY KIT | Serono-Baker Diagnostics, Inc. | 1989-03-08 | 28 | 0 |
| K884794 | PROGESTERONE SEROZYME IMMUNOENZYMETRIC ASSAY | Serono-Baker Diagnostics, Inc. | 1989-02-02 | 78 | 0 |
| K884683 | FERRITIN SEROZYME IMMUNOENZYMETRIC ASSAY | Serono-Baker Diagnostics, Inc. | 1988-12-27 | 49 | 0 |
| K883539 | SR1 SYSTEM AUTOMATED PHOTOMETRIC ANALYZER | Serono-Baker Diagnostics, Inc. | 1988-10-31 | 76 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda