Company ยท US
Chembio Diagnostic Systems, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1992 to 2020. Name variants (Inc, Corp, punctuation) are merged.
7510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 3, 2020 | K200506 | DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader Chembio Diagnostic Systems | QFO |
| Aug 14, 2001 | K011551 | SURE CHECK PREGNANCY TEST Chembio Diagnostic Systems, Inc. | LCX |
| Aug 14, 2001 | K011550 | HCG STAT PAK ULTRA-FAST Chembio Diagnostic Systems, Inc. | JHI |
| May 2, 2001 | K010244 | SURE CHECK OVULATION PREDICTOR Chembio Diagnostic Systems, Inc. | CEP |
| Feb 12, 1999 | K981913 | PREVUE(TM) BORRELIA BURGDORFERI ANTIBODY DETECTION ASSAY Chembio Diagnostic Systems, Inc. | LSR |
| Jun 24, 1996 | K961965 | SURE CHECK PREGNANCY TEST Chembio Diagnostic Systems, Inc. | LCX |
| Dec 24, 1992 | K923925 | HCG STAT-PAK Chembio Diagnostic Systems, Inc. | JHI |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||