HEMOGLOBIN A2 TESTING SYSTEM— 510(k) K771649
Substantially EquivalentIsolab, Inc.
FDA 510(k) clearance K771649 for HEMOGLOBIN A2 TESTING SYSTEM, Substantially Equivalent on 1977-10-07. Applicant: Isolab, Inc.. Device class: 2.
Clearance details
- Applicant
- Isolab, Inc.
- Product code
- Code JBD
- Device class
- Class 2
- Regulation
- 21 CFR 864.7440
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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More clearances from Isolab, Inc.
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