510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K132085Substantially Equivalent

One Step Hcg Test Strip, One Step Hcg Test Cassette, One Step Hcg Test Midstream

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

K132085 is the FDA 510(k) clearance record for ONE STEP HCG TEST STRIP, ONE STEP HCG TEST CASSETTE, ONE STEP HCG TEST MIDSTREAM, a class II device, cleared for Co-Innovation Biotech Co., Ltd. on under FDA product code LCX (Kit, Test, Pregnancy, Hcg, Over The Counter). FDA records list 10 510(k) clearances for Co-Innovation Biotech Co., Ltd., from to . As of , FDA records show no recalls naming K132085.

Clearance record

Decision date
Received
(130 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
Co-Innovation Biotech Co., Ltd. # 13 Yanyuan Rd.. Tianhe District, Guangzhou, Guangdong, 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