Cleared Traditional

ONE STEP HCG TEST STRIP, ONE STEP HCG TEST CASSETTE, ONE STEP HCG TEST MIDSTREAM

K132085 · Co-Innovation Biotech Co., Ltd. · Chemistry
Nov 2013
Decision
130d
Days
Class 2
Risk

About This 510(k) Submission

K132085 is an FDA 510(k) clearance for the ONE STEP HCG TEST STRIP, ONE STEP HCG TEST CASSETTE, ONE STEP HCG TEST MIDSTREAM, a Kit, Test, Pregnancy, Hcg, Over The Counter (Class II — Special Controls, product code LCX), submitted by Co-Innovation Biotech Co., Ltd. (Guangzhou, Guangdong, CN). The FDA issued a Cleared decision on November 12, 2013, 130 days after receiving the submission on July 5, 2013. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K132085 FDA.gov
FDA Decision Cleared SESE
Date Received July 05, 2013
Decision Date November 12, 2013
Days to Decision 130 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code LCX — Kit, Test, Pregnancy, Hcg, Over The Counter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1155

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