The following data is part of a premarket notification filed by Pointe Scientific, Inc. with the FDA for Fructosamine Reagent Set, Calibrator, And Control Set.
| Device ID | K993590 |
| 510k Number | K993590 |
| Device Name: | FRUCTOSAMINE REAGENT SET, CALIBRATOR, AND CONTROL SET |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | POINTE SCIENTIFIC, INC. 1025 JOHN A. PAPALAS DR. Lincoln Park, MI 48146 |
| Contact | William F Walters Jr. |
| Correspondent | William F Walters Jr. POINTE SCIENTIFIC, INC. 1025 JOHN A. PAPALAS DR. Lincoln Park, MI 48146 |
| Product Code | LCP |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-10-22 |
| Decision Date | 1999-12-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811727013521 | K993590 | 000 |
| 00811727011091 | K993590 | 000 |
| 00811727011084 | K993590 | 000 |
| 00811727011077 | K993590 | 000 |