GAMMA FETAL BLEED SCREENING TEST— 510(k) K820647
Substantially EquivalentGamma Biologicals, Inc.
FDA 510(k) clearance K820647 for GAMMA FETAL BLEED SCREENING TEST, Substantially Equivalent on 1982-05-12. Applicant: Gamma Biologicals, Inc.. Device class: 2.
Clearance details
- Applicant
- Gamma Biologicals, Inc.
- Product code
- Code LIM
- Device class
- Class 2
- Regulation
- 21 CFR 864.7455
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walker, MI, US
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