510(k) K923153
- Device
- HEMOCARD, HEMOGLOBIN C ASSAY
- Applicant
- ISOLAB, INC.
- 510(k) number
- K923153
- Product code
- MLL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1994-01-27
- Date received
- 1992-06-29
- Regulation
- 864.7415
- Classification name
- Hemoglobin C (abnormal Hemoglobin Variant)
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- JANET D PERKINS
- Address
- Drawer 4350 Akron OH US 44321 44321
FDA Registration Numbers#
- 8023024
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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