Company ยท US
Seradyn, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1988 to 2007. Name variants (Inc, Corp, punctuation) are merged.
30510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JIT | Calibrator, Secondary | 2 |
| LCD | Enzyme Immunoassay, Gentamicin | 2 |
| LEG | Enzyme Immunoassay, Valproic Acid | 2 |
| LEH | Radioimmunoassay, Vancomycin | 2 |
| NWM | Immunoassay, Anti-Seizure Drug | 2 |
| DEF | Alpha-2-Hs-Glycoprotein, Antigen, Antiserum, Control | 1 |
| DHR | System, Test, Rheumatoid Factor | 1 |
| DIP | Enzyme Immunoassay, Diphenylhydantoin | 1 |
| GSA | Antisera, All Mycoplasma Spp. | 1 |
| JFT | Fluorometric, Cortisol | 1 |
| JIX | Calibrator, Multi-Analyte Mixture | 1 |
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | 1 |
| JJT | Enzyme Controls (Assayed And Unassayed) | 1 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 |
| JQX | Nephelometer, For Clinical Use | 1 |
| KLQ | Radioimmunoassay, Amikacin | 1 |
| KLT | Enzyme Immunoassay, Carbamazepine | 1 |
| KXT | Enzyme Immunoassay, Digoxin | 1 |
| LBZ | Enzyme Immunoassay, Quinidine | 1 |
| LCP | Assay, Glycosylated Hemoglobin | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 17, 2007 | K070645 | SERADYN QMS TOPIRAMATE Seradyn, Inc. | NWM |
| Jan 12, 2007 | K062966 | QMS LAMOTRIGINE ASSAY (REAGENTS), CALIBRATORS & CONTROLS Seradyn, Inc. | ORH |
| Sep 22, 2006 | K062204 | ARCHITECT CORTISOL ASSAY Seradyn, Inc. | JFT |
| Jul 21, 2006 | K060998 | QMS TOBRAMYCIN Seradyn, Inc. | LCR |
| Jun 15, 2006 | K060709 | MULTIGENT GENTAMICIN Seradyn, Inc. | LCD |
| Dec 23, 2005 | K052826 | QMS QUINIDINE. QMS QUINIDINE CALIBRATORS Seradyn, Inc. | LBZ |
| Nov 18, 2005 | K051211 | QMS ZONISAMIDE REAGENTS, CALIBRATORS AND CONTROLS Seradyn, Inc. | NWM |
| Nov 1, 2005 | K052815 | QMS AMIKACIN REAGENTS Seradyn, Inc. | KLQ |
| Apr 1, 2005 | K050419 | QMS VANCOMYCIN Seradyn, Inc. | LEH |
| Nov 3, 2004 | K042307 | ARCHITECT T-UPTAKE CALIBRATORS (A-F) AND CONTROLS (LOW, HIGH) Seradyn, Inc. | JIT |
| Feb 9, 2004 | K033674 | MULTIGENT HEMOGLOBIN A1C (REAGENTS), HB A1C CALIBRATORS AND HB A1C CONTROLS Seradyn, Inc. | LCP |
| Apr 28, 2003 | K030405 | QMS / MULTIGENT VALPROIC ACID REAGENT, PART #396075 Seradyn | LEG |
| Oct 24, 2002 | K023058 | QMS DIGOXIN REAGENT SYSTEM ON THE ABBOTT AEROSET SYSTEM Seradyn | KXT |
| Jun 15, 1998 | K981496 | COLOR-SLIDE RF Seradyn, Inc. | DHR |
| Jan 17, 1996 | K952544 | COLORSLIDER RUBELLA Seradyn, Inc. | LQN |
| Sep 9, 1994 | K942991 | QMS THEOPHYLLINE CS Seradyn, Inc. | LGS |
| Jun 2, 1994 | K940376 | QMS GENTAMICIN ASSAY Seradyn, Inc. | LCD |
| Jun 2, 1994 | K940374 | QMS CARBAMAZEPINE ASSAY Seradyn, Inc. | KLT |
| Mar 11, 1994 | K936208 | VALPROIC ACID Seradyn, Inc. | LEG |
| Feb 25, 1994 | K934388 | QMS PHENOBARBITAL Seradyn, Inc. | LFN |
| Mar 26, 1993 | K925326 | ELECTROPHORESIS CONTROL LEVEL 1 Seradyn, Inc. | JJY |
| Dec 23, 1992 | K924186 | LPIA-FERRITIN ASSAY Seradyn, Inc. | DEF |
| Aug 30, 1991 | K913562 | QMS - DIGOXIN Seradyn, Inc. | LCS |
| Jun 24, 1991 | K910833 | COLOR VUE TM- MYCOPLASMA PNEUMONIAE Seradyn, Inc. | GSA |
| Feb 27, 1991 | K910160 | ELECTROPHORESIS CONTROL Seradyn, Inc. | JIT |
| Feb 22, 1991 | K905623 | CK-MB IMMUNOASSAY CONTROL Seradyn, Inc. | JJT |
| Nov 6, 1990 | K904815 | QMS TM- PHENYTOIN Seradyn, Inc. | DIP |
| May 24, 1990 | K901695 | QUICK CHEM II Seradyn, Inc. | JJQ |
| Mar 28, 1989 | K885263 | QMS(TM) - THEOPHYLLINE Seradyn, Inc. | JQX |
| Jan 5, 1988 | K874413 | REAGENT A AND REAGENT B Seradyn, Inc. | JIX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 29, 2008 | Seradyn, Inc. Seradyn QMS Vancomycin reagents, Part Number: 0373589. Seradyn, Inc, Indianapolis, IN. Terminated |
LEH | K050419 |