SYPHILIS SEROLOGICAL REAGENTS— 510(k) K871226
Substantially EquivalentNew Horizons Diagnostics Co.
FDA 510(k) clearance K871226 for SYPHILIS SEROLOGICAL REAGENTS, Substantially Equivalent on 1987-05-28. Applicant: New Horizons Diagnostics Co.. Device class: 2.
Clearance details
- Applicant
- New Horizons Diagnostics Co.
- 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
- Columbia, MD, US
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More clearances from New Horizons Diagnostics Co.
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