The following data is part of a premarket notification filed by Pointe Scientific, Inc. with the FDA for Liquid Ggt (gamma Glutamyl Transferase) Reagent Set.
| Device ID | K973157 |
| 510k Number | K973157 |
| Device Name: | LIQUID GGT (GAMMA GLUTAMYL TRANSFERASE) REAGENT SET |
| Classification | Kinetic Method, Gamma-glutamyl Transpeptidase |
| 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 | JQB |
| CFR Regulation Number | 862.1360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-22 |
| Decision Date | 1997-10-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811727015037 | K973157 | 000 |
| 00811727016140 | K973157 | 000 |
| 00811727011138 | K973157 | 000 |
| 00811727011145 | K973157 | 000 |
| 00811727011152 | K973157 | 000 |
| 00811727012678 | K973157 | 000 |
| 00811727013019 | K973157 | 000 |
| 00811727013538 | K973157 | 000 |
| 00811727014252 | K973157 | 000 |
| 00811727014269 | K973157 | 000 |
| 00811727014276 | K973157 | 000 |
| 00811727014283 | K973157 | 000 |
| 00811727014740 | K973157 | 000 |
| 00811727015839 | K973157 | 000 |