510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K150022Substantially Equivalent

Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG Urine Pregnancy Test Cassette, Wondfo One Step HCG Urine Pregnancy Test Midstream

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

K150022 is the FDA 510(k) clearance record for Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG Urine Pregnancy Test Cassette, Wondfo One Step HCG Urine Pregnancy Test Midstream, a class II device, cleared for Guangzhou Wondfo Biotech Co., Ltd. on under FDA product code LCX (Kit, Test, Pregnancy, Hcg, Over The Counter). FDA records list 43 510(k) clearances for Guangzhou Wondfo Biotech Co., Ltd., from to . As of , FDA records show no recalls naming K150022.

Clearance record

Decision date
Received
(213 days to decision)
Product code
LCX Kit, Test, Pregnancy, Hcg, Over The Counter
Regulation
21 CFR 862.1155
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Guangzhou Wondfo Biotech Co., Ltd. Wondfo Scientech Park, S. China Univ. Of Technology, Guangzhou, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LCX

Trailing 12 months

FDA records hold no clearances under product code LCX in the trailing twelve months.

FDA records show no clearances under product code LCX in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LCX, 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 20260
October 20260