CROMATEST SYPHILIS DIAGNOSTIC— 510(k) K904496
Substantially EquivalentBiotrax, Inc.
FDA 510(k) clearance K904496 for CROMATEST SYPHILIS DIAGNOSTIC, Substantially Equivalent on 1991-07-24. Applicant: Biotrax, Inc.. Device class: 2.
Clearance details
- Applicant
- Biotrax, Inc.
- Product code
- Code GMQ
- Device class
- Class 2
- Regulation
- 21 CFR 866.3820
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Baltimore, MD, US
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More clearances from Biotrax, Inc.
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