The following data is part of a premarket notification filed by Drew Scientific Ltd. with the FDA for 745 Glycomat.
| Device ID | K933287 |
| 510k Number | K933287 |
| Device Name: | 745 GLYCOMAT |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | DREW SCIENTIFIC LTD. 12 BARLEY MOW PASSAGE CHISWICK London W4 4ph Uk, GB |
| Contact | Andrew Kenney |
| Correspondent | Andrew Kenney DREW SCIENTIFIC LTD. 12 BARLEY MOW PASSAGE CHISWICK London W4 4ph Uk, GB |
| Product Code | LCP |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-07-06 |
| Decision Date | 1993-09-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817274020173 | K933287 | 000 |