The following data is part of a premarket notification filed by Pointe Scientific, Inc. with the FDA for Hemoglobin A1c Reagent Set.
| Device ID | K031539 |
| 510k Number | K031539 |
| Device Name: | HEMOGLOBIN A1C REAGENT SET |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | POINTE SCIENTIFIC, INC. 1025 JOHN A. PAPALAS DR. Lincoln Park, MI 48146 |
| Contact | William F Walters |
| Correspondent | William F Walters 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 | 2003-05-16 |
| Decision Date | 2003-08-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811727015044 | K031539 | 000 |
| 03661540304293 | K031539 | 000 |
| 03661540304675 | K031539 | 000 |
| 00811727016164 | K031539 | 000 |
| 00817274021736 | K031539 | 000 |
| 00817274021750 | K031539 | 000 |
| 00817274021767 | K031539 | 000 |
| 00817274021774 | K031539 | 000 |
| 00811727011503 | K031539 | 000 |
| 00811727011510 | K031539 | 000 |
| 00811727011534 | K031539 | 000 |
| 00811727011541 | K031539 | 000 |
| 00811727013545 | K031539 | 000 |
| 00811727013569 | K031539 | 000 |
| 00811727014535 | K031539 | 000 |
| 00811727014542 | K031539 | 000 |
| 00811727014559 | K031539 | 000 |
| 03661540304286 | K031539 | 000 |