The following data is part of a premarket notification filed by Drew Scientific Ltd. with the FDA for Glycomat Green Hba2 Estimation Reagent Kit.
| Device ID | K924496 |
| 510k Number | K924496 |
| Device Name: | GLYCOMAT GREEN HBA2 ESTIMATION REAGENT KIT |
| Classification | Hemoglobin A2 Quantitation |
| Applicant | DREW SCIENTIFIC LTD. 12 BARLEY MOW PASSAGE CHISWICK London W4 4ph Uk, GB |
| Contact | K. R Drew |
| Correspondent | K. R Drew DREW SCIENTIFIC LTD. 12 BARLEY MOW PASSAGE CHISWICK London W4 4ph Uk, GB |
| Product Code | JPD |
| CFR Regulation Number | 864.7400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-09-04 |
| Decision Date | 1992-11-16 |