510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K954685Substantially Equivalent

Uritest - Nitrite in Urine Test

Tcpi, Inc., Beverly MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K954685 is the FDA 510(k) clearance record for URITEST - NITRITE IN URINE TEST, a class I device, cleared for Tcpi, Inc. on under FDA product code JMT (Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)). FDA records list 3 510(k) clearances for Tcpi, Inc., from to . As of , FDA records show no recalls naming K954685.

Clearance record

Decision date
Received
(285 days to decision)
Product code
JMT Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)
Regulation
21 CFR 862.1510
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Tcpi, Inc. 15 Oak St., Beverly MA
510(k) summary
Summary
Third party review
No

Clearances, product code JMT

Trailing 12 months
1 clearance under product code JMT in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code JMT, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260