Chembio Diagnostic Systems, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Chembio Diagnostic Systems, Inc.” (first 1992, latest 2020), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 93 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 93 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Chembio Diagnostic Systems, Inc. took a median 93 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 133 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JHI | Visual, Pregnancy Hcg, Prescription Use | 2 | 2 |
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | 2 | 2 |
| CEP | Radioimmunoassay, Luteinizing Hormone | 1 | 1 |
| LSR | Reagent, Borrelia Serological Reagent | 1 | 1 |
| QFO | Zika Virus Serological Reagents | 1 | 1 |
Review panels
- Clinical Chemistry (5)
- Microbiology (2)
Most recent Chembio Diagnostic Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K200506 | DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader | QFO | 2020-06-03 | 93 |
| K011551 | SURE CHECK PREGNANCY TEST | LCX | 2001-08-14 | 88 |
| K011550 | HCG STAT PAK ULTRA-FAST | JHI | 2001-08-14 | 88 |
| K010244 | SURE CHECK OVULATION PREDICTOR | CEP | 2001-05-02 | 97 |
| K981913 | PREVUE(TM) BORRELIA BURGDORFERI ANTIBODY DETECTION ASSAY | LSR | 1999-02-12 | 256 |
| K961965 | SURE CHECK PREGNANCY TEST | LCX | 1996-06-24 | 35 |
| K923925 | HCG STAT-PAK | JHI | 1992-12-24 | 141 |
Recalls
openFDA lists no recalls under a recalling firm named Chembio Diagnostic Systems, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Chembio Diagnostic Systems, Inc. is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT01032902: Evaluation of the Performance of Chembio Diagnostics Systems, Inc. DPP® HIV 1/2 Rapid Test (Completed, started 2010-01)
Frequently asked questions
How many FDA 510(k) clearances are listed under Chembio Diagnostic Systems, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Chembio Diagnostic Systems, Inc.” (first 1992, latest 2020), across 5 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Chembio Diagnostic Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Chembio Diagnostic Systems, Inc. is 93 days.
Which FDA product codes appear under Chembio Diagnostic Systems, Inc.?
The most frequent FDA product codes under this applicant name are JHI (Visual, Pregnancy Hcg, Prescription Use, 2); LCX (Kit, Test, Pregnancy, Hcg, Over The Counter, 2); CEP (Radioimmunoassay, Luteinizing Hormone, 1).
Next steps
- See all 7 Chembio Diagnostic Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JHI, Chembio Diagnostic Systems, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.