The following data is part of a premarket notification filed by Pointe Scientific, Inc. with the FDA for Liquid Glucose (oxidase) Reagent Set.
| Device ID | K970781 |
| 510k Number | K970781 |
| Device Name: | LIQUID GLUCOSE (OXIDASE) REAGENT SET |
| Classification | Glucose Oxidase, Glucose |
| 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 | CGA |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-04 |
| Decision Date | 1997-04-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811727014214 | K970781 | 000 |
| 00817274021606 | K970781 | 000 |
| 00817274021613 | K970781 | 000 |
| 00817274021637 | K970781 | 000 |
| 00817274021644 | K970781 | 000 |
| 00817274021651 | K970781 | 000 |
| 00817274021668 | K970781 | 000 |
| 00811727011268 | K970781 | 000 |
| 00811727011275 | K970781 | 000 |
| 00811727011282 | K970781 | 000 |
| 00811727012692 | K970781 | 000 |
| 00811727013033 | K970781 | 000 |
| 00811727014191 | K970781 | 000 |
| 00811727014207 | K970781 | 000 |
| 00817274021590 | K970781 | 000 |