The following data is part of a premarket notification filed by Sigma Chemical Co. with the FDA for Dehydrogenose, Glucose Phosphate.
| Device ID | K790211 |
| 510k Number | K790211 |
| Device Name: | DEHYDROGENOSE, GLUCOSE PHOSPHATE |
| Classification | Glucose-6-phosphate Dehydrogenase (erythrocytic), Quantitative |
| Applicant | SIGMA CHEMICAL CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JBL |
| CFR Regulation Number | 864.7360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-01-31 |
| Decision Date | 1979-03-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05391516745680 | K790211 | 000 |
| 05391516743228 | K790211 | 000 |
| 05391516741552 | K790211 | 000 |