510(k) K874429
- Device
- HEMOGLOBIN DETERMINATION TEST KIT HGB S-100 & 12
- Applicant
- HF SCIENTIFIC, INC.
- 510(k) number
- K874429
- Product code
- GIQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-02-04
- Date received
- 1987-10-28
- Regulation
- 864.7415
- Classification name
- Hemoglobin S
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- BARBARA H SNEADE
- Address
- 3052 Metro Pkwy. SE Ft. Myers FL US 33916 33916
FDA Registration Numbers#
- 8023024
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GIQ #
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