HEMACHECK— 510(k) K781562
Substantially EquivalentVickers America Medical Corp.
FDA 510(k) clearance K781562 for HEMACHECK, Substantially Equivalent on 1978-11-15. Applicant: Vickers America Medical Corp.. Device class: 2.
Clearance details
- Applicant
- Vickers America Medical Corp.
- Product code
- Code GKL
- Device class
- Class 2
- Regulation
- 21 CFR 864.5200
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code GKL
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