510(k) K790211
- Device
- DEHYDROGENOSE, GLUCOSE PHOSPHATE
- Applicant
- SIGMA CHEMICAL CO.
- 510(k) number
- K790211
- Product code
- JBL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1979-03-15
- Date received
- 1979-01-31
- Regulation
- 864.7360
- Classification name
- Glucose-6-phosphate Dehydrogenase (erythrocytic), Quantitative
- Medical specialty
- Hematology
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3050015
- 9681576
- 3011240982
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JBL #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K990957 | ASTORIA-PACIFIC SPOTCHECK G6PD KIT 50 HR, MODEL 80-3000-13K | Astoria-Pacific, Inc. | 1999-05-11 |
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