The following data is part of a premarket notification filed by Tcpi, Inc. with the FDA for Health Check Uri-test Protein In Urine.
| Device ID | K972960 |
| 510k Number | K972960 |
| Device Name: | HEALTH CHECK URI-TEST PROTEIN IN URINE |
| Classification | Indicator Method, Protein Or Albumin (urinary, Non-quant.) |
| Applicant | TCPI, INC. 15 OAK ST. Beverly Farms, MA 01915 |
| Contact | Fran White |
| Correspondent | Fran White TCPI, INC. 15 OAK ST. Beverly Farms, MA 01915 |
| Product Code | JIR |
| CFR Regulation Number | 862.1645 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-11 |
| Decision Date | 1998-10-07 |