The following data is part of a premarket notification filed by Alladin Diagnostic, Inc. with the FDA for Glucose-6-phosphate Dehydrogenase.
| Device ID | K823900 |
| 510k Number | K823900 |
| Device Name: | GLUCOSE-6-PHOSPHATE DEHYDROGENASE |
| Classification | Assay, Erythrocytic Glucose-6-phosphate Dehydrogenase |
| Applicant | ALLADIN DIAGNOSTIC, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KQE |
| CFR Regulation Number | 864.7360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-12-30 |
| Decision Date | 1983-02-07 |