LATEX AGGLUTINATION TEST— 510(k) K851132
Substantially EquivalentNew Horizons Diagnostics Co.
FDA 510(k) clearance K851132 for LATEX AGGLUTINATION TEST, Substantially Equivalent on 1985-07-05. Applicant: New Horizons Diagnostics Co.. Device class: 1.
Clearance details
- Applicant
- New Horizons Diagnostics Co.
- Product code
- Code GTZ
- Device class
- Class 1
- Regulation
- 21 CFR 866.3740
- 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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