HEMOCARD, HEMOGLOBIN C ASSAY
FDA 510(k) clearance K923153 · decided 1994-01-27
Clearance details
- K-number
- K923153
- Device name
- HEMOCARD, HEMOGLOBIN C ASSAY
- Applicant
- Isolab, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-06-29
- Decision date
- 1994-01-27
- Days to decision
- 577 days
- Clearance type
- Traditional
- Product code
- MLL
- Device class
- 2
- Regulation number
- 864.7415
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Akron, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.