SEJOY hCG One Step Pregnancy Test Strip, SEJOY hCG One Step Pregnancy Test Cassette, SEJOY hCG One Step Pregnancy Test Midstream— 510(k) K212447

Substantially Equivalent

Hangzhou Sejoy Electronics & Instruments Co., Ltd.

FDA 510(k) clearance K212447 for SEJOY hCG One Step Pregnancy Test Strip, SEJOY hCG One Step Pregnancy Test Cassette, SEJOY hCG One Step Pregnancy Test Midstream, Substantially Equivalent on 2022-02-18. Applicant: Hangzhou Sejoy Electronics & Instruments Co., Ltd..

Clearance details

Applicant
Hangzhou Sejoy Electronics & Instruments Co., Ltd.
Product code
Code LCX
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Hangzhou City, CN
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