The following data is part of a premarket notification filed by Tcpi, Inc. with the FDA for Uritest - Nitrite In Urine Test.
| Device ID | K954685 |
| 510k Number | K954685 |
| Device Name: | URITEST - NITRITE IN URINE TEST |
| Classification | Diazo (colorimetric), Nitrite (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 | JMT |
| CFR Regulation Number | 862.1510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-11 |
| Decision Date | 1996-07-22 |
| Summary: | summary |