The following data is part of a premarket notification filed by Tcpi, Inc. with the FDA for Health Check Uri-test Glucose In Urine Test.
| Device ID | K954968 |
| 510k Number | K954968 |
| Device Name: | HEALTH CHECK URI-TEST GLUCOSE IN URINE TEST |
| Classification | Method, Enzymatic, Glucose (urinary, Non-quantitative) |
| 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 | JIL |
| CFR Regulation Number | 862.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-27 |
| Decision Date | 1996-07-26 |