REAGENT, LYOPHILIZED ANTI-STREPTOLYSIN O— 510(k) K760096
Substantially EquivalentGamma Biologicals, Inc.
FDA 510(k) clearance K760096 for REAGENT, LYOPHILIZED ANTI-STREPTOLYSIN O, Substantially Equivalent on 1976-08-03. Applicant: Gamma Biologicals, Inc.. Device class: 1.
Clearance details
- Applicant
- Gamma Biologicals, Inc.
- Product code
- Code GTQ
- Device class
- Class 1
- Regulation
- 21 CFR 866.3720
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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