The following data is part of a premarket notification filed by Pointe Scientific, Inc. with the FDA for Glycohemoglobin, In-vitro Diagnostic Reagent Set.
| Device ID | K860572 |
| 510k Number | K860572 |
| Device Name: | GLYCOHEMOGLOBIN, IN-VITRO DIAGNOSTIC REAGENT SET |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | POINTE SCIENTIFIC, INC. P.O. BOX 8569 Detroit, MI 48224 |
| Contact | Janusz M Szyszko |
| Correspondent | Janusz M Szyszko POINTE SCIENTIFIC, INC. P.O. BOX 8569 Detroit, MI 48224 |
| Product Code | LCP |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-02-14 |
| Decision Date | 1986-05-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811727014238 | K860572 | 000 |
| 00811727014221 | K860572 | 000 |
| 00811727011305 | K860572 | 000 |