Letsgetchecked Inc. (Formerly Privapath Diagnostics Inc.): FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Letsgetchecked Inc. (Formerly Privapath Diagnostics Inc.)”, plus 1 De Novo decision, across 1 product code in 1 review panel. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QYA | System For Detection Of Nucleic Acid From Non-Viral Microorganism(S) Causing Stis Using Specimens Collected At Home | 1 | 0 |
Review panels
- Microbiology (1)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN200070 | De Novo | System For Detection Of Nucleic Acid From Non-Viral Microorganism(S) Causing Stis Using Specimens Collected At Home | 2023-11-15 |
Recalls
openFDA lists no recalls under a recalling firm named Letsgetchecked Inc. (Formerly Privapath Diagnostics 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Letsgetchecked Inc. (Formerly Privapath Diagnostics Inc.)?
FDA lists 0 510(k) clearances under the applicant name “Letsgetchecked Inc. (Formerly Privapath Diagnostics Inc.)”, plus 1 De Novo decision, across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
Which FDA product codes appear under Letsgetchecked Inc. (Formerly Privapath Diagnostics Inc.)?
The most frequent FDA product codes under this applicant name are QYA (System For Detection Of Nucleic Acid From Non-Viral Microorganism(S) Causing Stis Using Specimens Collected At Home, 1).
Next steps
- See all 0 Letsgetchecked Inc. (Formerly Privapath Diagnostics Inc.) clearances with predicates and recalls
- Run predicate analysis for product code QYA, Letsgetchecked Inc. (Formerly Privapath Diagnostics 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.