510(k) K123050— EGENS ONE STEP HCG URINE PREGNANCY TEST KIT(S) (STRIP, CASSETTE, MIDSTREAM I AND MIDSTREAM II)

Substantially Equivalent

Nantong Biotechnology Co., Ltd.

Clearance details

Applicant: Nantong Biotechnology Co., Ltd.
Product code: Code LCX
Advisory panel: Clinical Chemistry
Date received: 2012-09-28
Decision date: 2013-02-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gaithersburg, MD, US

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