510(k) K942276
- Device
- QUIK-SEP QUANTITATIVE HEMOGLOBIN S ASSAY
- Applicant
- ISOLAB, INC.
- 510(k) number
- K942276
- Product code
- GIQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-01-20
- Date received
- 1994-05-10
- Regulation
- 864.7415
- Classification name
- Hemoglobin S
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JANET D PERKINS
- Address
- Drawer 4350 Akron OH US 44321 44321
FDA Registration Numbers#
- 8023024
Source Documents#
Other 510(k) Records For Product Code GIQ #
Legacy Summary#
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FDA Review#
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