510(k) K132085— ONE STEP HCG TEST STRIP, ONE STEP HCG TEST CASSETTE, ONE STEP HCG TEST MIDSTREAM

Substantially Equivalent

Co-Innovation Biotech Co., Ltd.

Clearance details

Applicant: Co-Innovation Biotech Co., Ltd.
Product code: Code LCX
Advisory panel: Clinical Chemistry
Date received: 2013-07-05
Decision date: 2013-11-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Guangzhou, Guangdong, CN

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