The following data is part of a premarket notification filed by Pointe Scientific, Inc. with the FDA for Bun (liquid) Reagent Set.
| Device ID | K972671 |
| 510k Number | K972671 |
| Device Name: | BUN (LIQUID) REAGENT SET |
| Classification | Urease And Glutamic Dehydrogenase, Urea Nitrogen |
| 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 | CDQ |
| CFR Regulation Number | 862.1770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-16 |
| Decision Date | 1997-07-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811727014955 | K972671 | 000 |
| 00817439020284 | K972671 | 000 |
| 00817439020291 | K972671 | 000 |
| 00817439020307 | K972671 | 000 |
| 00811727010537 | K972671 | 000 |
| 00811727010544 | K972671 | 000 |
| 00811727010551 | K972671 | 000 |
| 00811727012593 | K972671 | 000 |
| 00811727012951 | K972671 | 000 |
| 00811727013378 | K972671 | 000 |
| 00811727013439 | K972671 | 000 |
| 00811727013873 | K972671 | 000 |
| 00811727013880 | K972671 | 000 |
| 00811727013897 | K972671 | 000 |
| 00811727013903 | K972671 | 000 |
| 00811727014658 | K972671 | 000 |
| 00811727016058 | K972671 | 000 |