510(k) K253453
- Device
- Metrix COVID Test; Metrix COVID Test Pro
- Applicant
- Aptitude Medical Systems, Inc.
- 510(k) number
- K253453
- Product code
- QWB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-08-07
- Date received
- 2025-10-06
- Regulation
- 866.3984
- Classification name
- Over-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Specimens
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Tyler Chozinski
- Address
- 125 Cremona D Suite 100 Goleta CA US 93117 93117
FDA Registration Numbers#
- 3034617817