Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Serono Diagnostics, Inc. — Predicate Candidate Screening
25 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
55 daysmedian FDA review time
93 days90th percentile
25clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K953598 | SERIES 9100 PLUS AUTOMATED DIFFERENTIAL HEMATOLOGY ANALYZERS | Serono Diagnostics, Inc. | 1996-03-11 | 223 | 0 |
| K942051 | SR1 DHEA-S ENZYME IMMUNOASSAY | Serono Diagnostics, Inc. | 1994-07-13 | 76 | 0 |
| K883085 | T3 UPTAKE SEROZYME ENZYME IMMUNO KT/MAG SOLID PHAS | Serono Diagnostics, Inc. | 1988-09-09 | 49 | 0 |
| K882340 | LH SEROZYME IMMUNOENZYMETRIC ASSAY KIT,MAG SOL PHA | Serono Diagnostics, Inc. | 1988-08-08 | 62 | 0 |
| K880388 | T3 SEROZYME ENZYMEIMMUNOASSAY KIT, MAG SOLID PHASE | Serono Diagnostics, Inc. | 1988-03-03 | 35 | 0 |
| K874866 | T4 SEROZYME ENZYMEIMMUNOASSAY KIT/MAG. SOLID PHASE | Serono Diagnostics, Inc. | 1988-02-11 | 76 | 0 |
| K873431 | PROGESTERONE MAIA RADIOIMMUNO ASSAY KIT MAG SLD PH | Serono Diagnostics, Inc. | 1987-10-20 | 55 | 0 |
| K873186 | LH MAIACLONE IMMUNORADIO. ASSAY KIT, MAG SOLID PHA | Serono Diagnostics, Inc. | 1987-09-29 | 48 | 0 |
| K873400 | PROLACTIN MAIACLONE IMMUNORADIO. KIT, MAG SOL PHA | Serono Diagnostics, Inc. | 1987-09-25 | 32 | 0 |
| K872862 | PRL SEROZYME IMMUNOENZ. ASSAY KIT, MAG. SOLID PHAS | Serono Diagnostics, Inc. | 1987-09-18 | 59 | 0 |
| K873033 | HCG SEROZYME IMMUNOENZYM ASSAY KIT/MAG SOLID PHASE | Serono Diagnostics, Inc. | 1987-09-14 | 41 | 0 |
| K872727 | LH SEROZYME IMMUNOENZYMETRIC ASSAY KIT, MAG. PHASE | Serono Diagnostics, Inc. | 1987-08-05 | 28 | 0 |
| K872897 | TSH SEROZYME IMMUNOENZYMETRIC KIT, MAG. SOLID PHA. | Serono Diagnostics, Inc. | 1987-07-31 | 8 | 0 |
| K872627 | FSH SEROZYME IMMUNOENZYMETRIC ASSAY KIT/MAG SEP PH | Serono Diagnostics, Inc. | 1987-07-21 | 15 | 0 |
| K870946 | MONABRITE CHLAMYDIA TRACHOMATIS DIR. SPECIMEN TEST | Serono Diagnostics, Inc. | 1987-04-29 | 51 | 0 |
| K864565 | MONABRITE CYTOMEGALOVIRUS (CMV) IFA KIT | Serono Diagnostics, Inc. | 1987-02-19 | 92 | 0 |
| K864677 | TSH MAIACLONE IMMUNORADIOMETRIC ASSAY KIT/MAG SEP | Serono Diagnostics, Inc. | 1987-01-07 | 36 | 0 |
| K862813 | FSH MAIACLONE IMMUNORADIOMETRIC ASSAY KIT | Serono Diagnostics, Inc. | 1986-09-16 | 54 | 0 |
| K862262 | HCG MAIACLONE IMMUNORADIOMETRIC KIT/KIT COMPONENTS | Serono Diagnostics, Inc. | 1986-07-29 | 46 | 0 |
| K861379 | MONABRITE RESPIR SYNCYTIAL VIRUS(RSV) TEST KIT | Serono Diagnostics, Inc. | 1986-07-16 | 93 | 0 |
| K861361 | ESTRADIOL MAIA RIA KIT MAGNETIC SEPARATION PHASE | Serono Diagnostics, Inc. | 1986-06-27 | 78 | 0 |
| K854615 | MONABRITE CHLAMYDIA TRACH CULTURE CONFIRMATION TES | Serono Diagnostics, Inc. | 1986-01-28 | 71 | 0 |
| K842965 | GASTRIN RADIOIMMUNOASSAY TEST KIT | Serono Diagnostics, Inc. | 1984-10-11 | 76 | 0 |
| K842966 | RENIN RADIOIMMUNOASSAY TEST KIT | Serono Diagnostics, Inc. | 1984-10-11 | 76 | 0 |
| K833396 | C-PEPTIDE RADIOIMMUNOASSAY TEST KIT | Serono Diagnostics, Inc. | 1984-04-13 | 196 | 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