The following data is part of a premarket notification filed by Pointe Scientific, Inc. with the FDA for Alcohol Reagent Set.
| Device ID | K972725 |
| 510k Number | K972725 |
| Device Name: | ALCOHOL REAGENT SET |
| Classification | Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method |
| 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 | DIC |
| CFR Regulation Number | 862.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-21 |
| Decision Date | 1997-09-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811727010063 | K972725 | 000 |
| 00811727010056 | K972725 | 000 |