510(k) K820630
- Device
- QUIK-SEP HEMOGLOBIN F ASSAY & CONTROL
- Applicant
- ISOLAB, INC.
- 510(k) number
- K820630
- Product code
- JPC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-06-25
- Date received
- 1982-03-08
- Regulation
- 864.7455
- Classification name
- Hemoglobin F Quantitation
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 4221 Richmond Rd., NW Walker MI US 49534 49534
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases