HEMOCARD HEMOGLOBIN E— 510(k) K930070
Substantially EquivalentIsolab, Inc.
FDA 510(k) clearance K930070 for HEMOCARD HEMOGLOBIN E, Substantially Equivalent on 1993-04-08. Applicant: Isolab, Inc.. Device class: 1.
Clearance details
- Applicant
- Isolab, Inc.
- Product code
- Code CKA
- Device class
- Class 1
- Regulation
- 21 CFR 862.1030
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Akron, OH, US
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