510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K252607Substantially Equivalent

AllTest Urinary Tract Infection Test

Hangzhou AllTest Biotech Co.,Ltd, Hangzhou, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K252607 is the FDA 510(k) clearance record for AllTest Urinary Tract Infection Test, a class I device, cleared for Hangzhou AllTest Biotech Co., Ltd. on under FDA product code JMT (Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)). FDA records list 14 510(k) clearances for Hangzhou AllTest Biotech Co., Ltd., from to . As of , FDA records show no recalls naming K252607.

Clearance record

Decision date
Received
(73 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
Hangzhou AllTest Biotech Co., Ltd. #550 Yinhai St., Hangzhou, CN
510(k) summary
Summary PDF
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