The following data is part of a premarket notification filed by Pointe Scientific, Inc. with the FDA for Pointe 750 Glycometer.
| Device ID | K920449 |
| 510k Number | K920449 |
| Device Name: | POINTE 750 GLYCOMETER |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | POINTE SCIENTIFIC, INC. 1025 JOHN A. PAPALAS DR. Lincoln Park, MI 48146 |
| Contact | Walters, Jr. |
| Correspondent | 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 | 1992-02-02 |
| Decision Date | 1992-07-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811727014245 | K920449 | 000 |
| 00811727011336 | K920449 | 000 |
| 00811727011329 | K920449 | 000 |