Seradyn, Inc.
Indianapolis, IN, US
Seradyn, Inc. appears in FDA device records in Indianapolis, IN. FDA records list 30 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show one recall for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 30 510(k) clearances for Seradyn, Inc. between 1988 and 2007. The busiest year on record is 1994, with 5. The most recent is 2007, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1988 | 1 |
| 1989 | 1 |
| 1990 | 2 |
| 1991 | 4 |
| 1992 | 1 |
| 1993 | 1 |
| 1994 | 5 |
| 1996 | 1 |
| 1998 | 1 |
| 2002 | 1 |
| 2003 | 1 |
| 2004 | 2 |
| 2005 | 4 |
| 2006 | 3 |
| 2007 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K070645 | SERADYN QMS TOPIRAMATE | NWM | Substantially Equivalent | |
| K062966 | QMS LAMOTRIGINE ASSAY (REAGENTS), CALIBRATORS & CONTROLS | ORH | Substantially Equivalent | |
| K062204 | ARCHITECT CORTISOL ASSAY | JFT | Substantially Equivalent | |
| K060998 | QMS TOBRAMYCIN | LCR | Substantially Equivalent | |
| K060709 | MULTIGENT GENTAMICIN | LCD | Substantially Equivalent | |
| K052826 | QMS QUINIDINE. QMS QUINIDINE CALIBRATORS | LBZ | Substantially Equivalent | |
| K051211 | QMS ZONISAMIDE REAGENTS, CALIBRATORS AND CONTROLS | NWM | Substantially Equivalent | |
| K052815 | QMS AMIKACIN REAGENTS | KLQ | Substantially Equivalent | |
| K050419 | QMS VANCOMYCIN | LEH | Substantially Equivalent | |
| K042307 | ARCHITECT T-UPTAKE CALIBRATORS (A-F) AND CONTROLS (LOW, HIGH) | JIT | Substantially Equivalent | |
| K033674 | MULTIGENT HEMOGLOBIN A1C (REAGENTS), HB A1C CALIBRATORS AND HB A1C CONTROLS | LCP | Substantially Equivalent | |
| K030405 | QMS / MULTIGENT VALPROIC ACID REAGENT, PART #396075 | LEG | Substantially Equivalent | |
| K023058 | QMS DIGOXIN REAGENT SYSTEM ON THE ABBOTT AEROSET SYSTEM | KXT | Substantially Equivalent | |
| K981496 | COLOR-SLIDE RF | DHR | Substantially Equivalent | |
| K952544 | COLORSLIDER RUBELLA | LQN | Substantially Equivalent | |
| K942991 | QMS THEOPHYLLINE CS | LGS | Substantially Equivalent | |
| K940376 | QMS GENTAMICIN ASSAY | LCD | Substantially Equivalent | |
| K940374 | QMS CARBAMAZEPINE ASSAY | KLT | Substantially Equivalent | |
| K936208 | VALPROIC ACID | LEG | Substantially Equivalent | |
| K934388 | QMS PHENOBARBITAL | LFN | Substantially Equivalent | |
| K925326 | ELECTROPHORESIS CONTROL LEVEL 1 | JJY | Substantially Equivalent | |
| K924186 | LPIA-FERRITIN ASSAY | DEF | Substantially Equivalent | |
| K913562 | QMS - DIGOXIN | LCS | Substantially Equivalent | |
| K910833 | COLOR VUE TM- MYCOPLASMA PNEUMONIAE | GSA | Substantially Equivalent | |
| K910160 | ELECTROPHORESIS CONTROL | JIT | Substantially Equivalent | |
| K905623 | CK-MB IMMUNOASSAY CONTROL | JJT | Substantially Equivalent | |
| K904815 | QMS TM- PHENYTOIN | DIP | Substantially Equivalent | |
| K901695 | QUICK CHEM II | JJQ | Substantially Equivalent | |
| K885263 | QMS(TM) - THEOPHYLLINE | JQX | Substantially Equivalent | |
| K874413 | REAGENT A AND REAGENT B | JIX | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- DEFAlpha-2-Hs-Glycoprotein, Antigen, Antiserum, Control
- GSAAntisera, All Mycoplasma Spp.
- LCPAssay, Glycosylated Hemoglobin
- JIXCalibrator, Multi-Analyte Mixture
- JITCalibrator, Secondary
- JJQColorimeter, Photometer, Spectrophotometer For Clinical Use
- JJTEnzyme Controls (Assayed And Unassayed)
- KLTEnzyme Immunoassay, Carbamazepine
- KXTEnzyme Immunoassay, Digoxin
- DIPEnzyme Immunoassay, Diphenylhydantoin
- LCDEnzyme Immunoassay, Gentamicin
- LBZEnzyme Immunoassay, Quinidine
- LEGEnzyme Immunoassay, Valproic Acid
- LGSFluorescence Polarization Immunoassay, Theophylline
- LCRFluorescent Immunoassay, Tobramycin
- JFTFluorometric, Cortisol
- NWMImmunoassay, Anti-Seizure Drug
- ORHLamotrigine Assay
- LQNLatex Agglutination Assay, Rubella
- JJYMulti-Analyte Controls, All Kinds (Assayed)
- JQXNephelometer, For Clinical Use
- LFNNephelometric Inhibition Immunoassay, Phenobarbital
- KLQRadioimmunoassay, Amikacin
- LCSRadioimmunoassay, Digoxin (125-I)
- LEHRadioimmunoassay, Vancomycin
- DHRSystem, Test, Rheumatoid Factor
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1102-2008 | Seradyn QMS Vancomycin reagents, Part Number: 0373589. Seradyn, Inc, Indianapolis, IN. | False negative test results due to Interfering substances (heterophile antibodies) in the patient's blood may produce erroneously low results. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain