The following data is part of a premarket notification filed by Pointe Scientific, Inc. with the FDA for Liquid Amylase (cnpg3) Reagent Set.
| Device ID | K940735 |
| 510k Number | K940735 |
| Device Name: | LIQUID AMYLASE (CNPG3) REAGENT SET |
| Classification | Saccharogenic, Amylase |
| 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 | CIJ |
| CFR Regulation Number | 862.1070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-02-17 |
| Decision Date | 1994-08-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811727013835 | K940735 | 000 |
| 00811727013422 | K940735 | 000 |
| 00811727010315 | K940735 | 000 |
| 00811727010308 | K940735 | 000 |
| 00811727010292 | K940735 | 000 |
| 00811727010285 | K940735 | 000 |
| 00817439020215 | K940735 | 000 |
| 00817439020192 | K940735 | 000 |
| 00811727015723 | K940735 | 000 |