HEMAQUIK— 510(k) K811400
Substantially EquivalentAccra Laboratories, Inc.
FDA 510(k) clearance K811400 for HEMAQUIK, Substantially Equivalent on 1981-06-18. Applicant: Accra Laboratories, Inc.. Device class: 1.
Clearance details
- Applicant
- Accra Laboratories, Inc.
- Product code
- Code IAF
- Device class
- Class 1
- Regulation
- 21 CFR 864.1850
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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