510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K960888Substantially Equivalent

Chek-Stix U.t.i. Self-Test

Bayer Corp., Elkhart IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K960888 is the FDA 510(k) clearance record for CHEK-STIX U.T.I. SELF-TEST, a class I device, cleared for Bayer Corp. on under FDA product code JMT (Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)). FDA records list 20 510(k) clearances for Bayer Corp., from to . As of , FDA records show no recalls naming K960888.

Clearance record

Decision date
Received
(123 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
Bayer Corp. 1884 Miles Ave., Elkhart IN
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