Simple 2 Test— 510(k) DEN200070

Name: FDA 510(k) clearance DEN200070
Creator: U.S. Food and Drug Administration
Published: 2023-11-15

Unknown

Letsgetchecked Inc. (Formerly Privapath Diagnostics Inc.)

FDA 510(k) clearance DEN200070 for Simple 2 Test, Unknown on 2023-11-15. Applicant: Letsgetchecked Inc. (Formerly Privapath Diagnostics Inc.). Device class: 2.

Clearance details

Applicant: Letsgetchecked Inc. (Formerly Privapath Diagnostics Inc.)
Product code: Code QYA
Device class: Class 2
Regulation: 21 CFR 866.3385
Advisory panel: Microbiology
Date received: 2020-11-16
Decision date: 2023-11-15
Decision: Unknown
Clearance type: Direct
Location: Dun Laoghaire, IE

View on FDA.gov ↗

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