# Chembio Diagnostic Systems, Inc.

- Location (FDA's records): Beverly, MA
- FDA decisions: 7 (1992–2020): 7 510(k) clearances
- Names in FDA's records: Chembio Diagnostic Systems, Inc. (6); Chembio Diagnostic Systems (1)
- Product codes: JHI (2), LCX (2), LSR (1), QFO (1), CEP (1)
- Predicates its devices cite: 3 (1 its own); citations of its devices by later devices: 1 (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
- Wampole Laboratories: 1 (https://510kreport.com/company/wampole-laboratories)
- InBios International, Inc.: 1 (https://510kreport.com/company/inbios-international)

## Its most-cited devices
- K923925: HCG Stat-Pak (1992), cited by 1

## Recent decisions
- K200506: DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader (Jun 3, 2020)
- K011550: HCG Stat Pak Ultra-Fast (Aug 14, 2001)
- K011551: Sure Check Pregnancy Test (Aug 14, 2001)
- K010244: Sure Check Ovulation Predictor (May 2, 2001)
- K981913: Prevue (TM) Borrelia Burgdorferi Antibody Detection Assay (Feb 12, 1999)
- K961965: Sure Check Pregnancy Test (Jun 24, 1996)
- K923925: HCG Stat-Pak (Dec 24, 1992)

Source page: https://510kreport.com/company/chembio-diagnostic-systems