The following data is part of a premarket notification filed by Pointe Scientific, Inc. with the FDA for Liquid Alkaline Phoshatase Reagent Set.
| Device ID | K973588 |
| 510k Number | K973588 |
| Device Name: | LIQUID ALKALINE PHOSHATASE REAGENT SET |
| Classification | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes |
| 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 | CJE |
| CFR Regulation Number | 862.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-22 |
| Decision Date | 1997-10-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811727014900 | K973588 | 000 |
| 00811727016010 | K973588 | 000 |
| 00817439020123 | K973588 | 000 |
| 00817439020130 | K973588 | 000 |
| 00817439020147 | K973588 | 000 |
| 00811727010148 | K973588 | 000 |
| 00811727010155 | K973588 | 000 |
| 00811727012531 | K973588 | 000 |
| 00811727012876 | K973588 | 000 |
| 00811727013392 | K973588 | 000 |
| 00811727013712 | K973588 | 000 |
| 00811727013729 | K973588 | 000 |
| 00811727013736 | K973588 | 000 |
| 00811727013743 | K973588 | 000 |
| 00811727014597 | K973588 | 000 |
| 00811727015709 | K973588 | 000 |