Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Seradyn, Inc. — Predicate Candidate Screening
28 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
79 daysmedian FDA review time
169 days90th percentile
28clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K070645 | SERADYN QMS TOPIRAMATE | Seradyn, Inc. | 2007-05-17 | 70 | 0 |
| K062966 | QMS LAMOTRIGINE ASSAY (REAGENTS), CALIBRATORS & CONTROLS | Seradyn, Inc. | 2007-01-12 | 105 | 0 |
| K062204 | ARCHITECT CORTISOL ASSAY | Seradyn, Inc. | 2006-09-22 | 52 | 0 |
| K060998 | QMS TOBRAMYCIN | Seradyn, Inc. | 2006-07-21 | 101 | 0 |
| K060709 | MULTIGENT GENTAMICIN | Seradyn, Inc. | 2006-06-15 | 91 | 0 |
| K052826 | QMS QUINIDINE. QMS QUINIDINE CALIBRATORS | Seradyn, Inc. | 2005-12-23 | 79 | 0 |
| K051211 | QMS ZONISAMIDE REAGENTS, CALIBRATORS AND CONTROLS | Seradyn, Inc. | 2005-11-18 | 191 | 0 |
| K052815 | QMS AMIKACIN REAGENTS | Seradyn, Inc. | 2005-11-01 | 28 | 0 |
| K050419 | QMS VANCOMYCIN | Seradyn, Inc. | 2005-04-01 | 42 | 1 |
| K042307 | ARCHITECT T-UPTAKE CALIBRATORS (A-F) AND CONTROLS (LOW, HIGH | Seradyn, Inc. | 2004-11-03 | 70 | 0 |
| K033674 | MULTIGENT HEMOGLOBIN A1C (REAGENTS), HB A1C CALIBRATORS AND | Seradyn, Inc. | 2004-02-09 | 77 | 0 |
| K981496 | COLOR-SLIDE RF | Seradyn, Inc. | 1998-06-15 | 49 | 0 |
| K952544 | COLORSLIDER RUBELLA | Seradyn, Inc. | 1996-01-17 | 229 | 0 |
| K942991 | QMS THEOPHYLLINE CS | Seradyn, Inc. | 1994-09-09 | 81 | 0 |
| K940376 | QMS GENTAMICIN ASSAY | Seradyn, Inc. | 1994-06-02 | 127 | 0 |
| K940374 | QMS CARBAMAZEPINE ASSAY | Seradyn, Inc. | 1994-06-02 | 127 | 0 |
| K936208 | VALPROIC ACID | Seradyn, Inc. | 1994-03-11 | 72 | 0 |
| K934388 | QMS PHENOBARBITAL | Seradyn, Inc. | 1994-02-25 | 169 | 0 |
| K925326 | ELECTROPHORESIS CONTROL LEVEL 1 | Seradyn, Inc. | 1993-03-26 | 156 | 0 |
| K924186 | LPIA-FERRITIN ASSAY | Seradyn, Inc. | 1992-12-23 | 125 | 0 |
| K913562 | QMS - DIGOXIN | Seradyn, Inc. | 1991-08-30 | 21 | 0 |
| K910833 | COLOR VUE TM- MYCOPLASMA PNEUMONIAE | Seradyn, Inc. | 1991-06-24 | 117 | 0 |
| K910160 | ELECTROPHORESIS CONTROL | Seradyn, Inc. | 1991-02-27 | 43 | 0 |
| K905623 | CK-MB IMMUNOASSAY CONTROL | Seradyn, Inc. | 1991-02-22 | 70 | 0 |
| K904815 | QMS TM- PHENYTOIN | Seradyn, Inc. | 1990-11-06 | 13 | 0 |
| K901695 | QUICK CHEM II | Seradyn, Inc. | 1990-05-24 | 44 | 0 |
| K885263 | QMS(TM) - THEOPHYLLINE | Seradyn, Inc. | 1989-03-28 | 95 | 0 |
| K874413 | REAGENT A AND REAGENT B | Seradyn, Inc. | 1988-01-05 | 69 | 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