QUIK-SEP QUANTITIVE HEMOGLOBIN S CONTROLS— 510(k) K942222
Substantially EquivalentIsolab, Inc.
FDA 510(k) clearance K942222 for QUIK-SEP QUANTITIVE HEMOGLOBIN S CONTROLS, Substantially Equivalent on 1995-01-20. Applicant: Isolab, Inc.. Device class: 2.
Clearance details
- Applicant
- Isolab, Inc.
- Product code
- Code JCM
- Device class
- Class 2
- Regulation
- 21 CFR 864.7415
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Akron, OH, US
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