# Seradyn, Inc.

- Location (FDA's records): Indianapolis, IN
- FDA decisions: 30 (1988–2007): 30 510(k) clearances
- Names in FDA's records: Seradyn, Inc. (28); Seradyn (2)
- Product codes: LCD (2), LEG (2), JIT (2), NWM (2), LCP (1), DEF (1), JJQ (1), KLQ (1), GSA (1), LQN (1), DHR (1), LEH (1)
- Predicates its devices cite: 10 (1 its own); citations of its devices by later devices: 7 (1 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Abbott Laboratories: 5 (https://510kreport.com/company/abbott-laboratories)
- Oxis Intl., Inc.: 2 (https://510kreport.com/company/oxis-intl)
- Tosoh Medics, Inc.: 1 (https://510kreport.com/company/tosoh-medics)
- Fujirebio Diagnostics,Inc.: 1 (https://510kreport.com/company/fujirebio-diagnostics)

## Firms that cite its devices most
- Ark Diagnostics, Inc.: 3 (https://510kreport.com/company/ark-diagnostics)
- Beckman Instruments, Inc.: 1 (https://510kreport.com/company/beckman-instruments)
- Biokit, S.A.: 1 (https://510kreport.com/company/biokit)
- Roche Diagnostics Corp.: 1 (https://510kreport.com/company/roche-diagnostics)

## Its most-cited devices
- K051211: QMS Zonisamide Reagents, Calibrators and Controls (2005), cited by 2
- K924186: Lpia-Ferritin Assay (1992), cited by 1
- K070645: Seradyn QMS Topiramate (2007), cited by 1
- K023058: QMS Digoxin Reagent System on the Abbott Aeroset System (2002), cited by 1
- K062966: QMS Lamotrigine Assay (Reagents), Calibrators & Controls (2007), cited by 1
- K062204: Architect Cortisol Assay (2006), cited by 1

## Recent decisions
- K070645: Seradyn QMS Topiramate (May 17, 2007)
- K062966: QMS Lamotrigine Assay (Reagents), Calibrators & Controls (Jan 12, 2007)
- K062204: Architect Cortisol Assay (Sep 22, 2006)
- K060998: QMS Tobramycin (Jul 21, 2006)
- K060709: Multigent Gentamicin (Jun 15, 2006)
- K052826: QMS Quinidine.  QMS Quinidine Calibrators (Dec 23, 2005)
- K051211: QMS Zonisamide Reagents, Calibrators and Controls (Nov 18, 2005)
- K052815: QMS Amikacin Reagents (Nov 1, 2005)

Source page: https://510kreport.com/company/seradyn