GONOSTAT GONOCOCCAL DETECTION KIT— 510(k) K991268
Substantially EquivalentSierra Diagnostics
FDA 510(k) clearance K991268 for GONOSTAT GONOCOCCAL DETECTION KIT, Substantially Equivalent on 1999-08-11. Applicant: Sierra Diagnostics. Device class: 2.
Clearance details
- Applicant
- Sierra Diagnostics
- Product code
- Code LSL
- Device class
- Class 2
- Regulation
- 21 CFR 866.3390
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Washington, DC, US
Recent devices under product code LSL
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