510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K203272Substantially Equivalent

Alltest Pregnancy Rapid Combo Test Cassette

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

K203272 is the FDA 510(k) clearance record for Alltest Pregnancy Rapid Combo Test Cassette, a class II device, cleared for Hangzhou AllTest Biotech Co., Ltd. on under FDA product code JHI (Visual, Pregnancy Hcg, Prescription Use). FDA records list 14 510(k) clearances for Hangzhou AllTest Biotech Co., Ltd., from to . As of , FDA records show no recalls naming K203272.

Clearance record

Decision date
Received
(451 days to decision)
Product code
JHI Visual, Pregnancy Hcg, Prescription Use
Regulation
21 CFR 862.1155
Device class
Class II
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 JHI

Trailing 12 months
1 clearance under product code JHI in the twelve months to October 2026, September 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code JHI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20261
October 20260