RST-SERIES CONTROL— 510(k) K800658
Substantially EquivalentGamma Biologicals, Inc.
FDA 510(k) clearance K800658 for RST-SERIES CONTROL, Substantially Equivalent on 1980-04-16. Applicant: Gamma Biologicals, Inc.. Device class: 2.
Clearance details
- Applicant
- Gamma Biologicals, Inc.
- Product code
- Code KSF
- Device class
- Class 2
- Regulation
- 21 CFR 864.9650
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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