David Home Pregnancy Test Cassette, David Professional Pregnancy Test Cassette— 510(k) K172627

Name: FDA 510(k) clearance K172627
Creator: U.S. Food and Drug Administration
Published: 2018-03-28

Substantially Equivalent

Runbio Biotech Co.,Ltd

FDA 510(k) clearance K172627 for David Home Pregnancy Test Cassette, David Professional Pregnancy Test Cassette, Substantially Equivalent on 2018-03-28. Applicant: Runbio Biotech Co.,Ltd. Device class: 2.

Clearance details

Applicant: Runbio Biotech Co.,Ltd
Product code: Code LCX
Device class: Class 2
Regulation: 21 CFR 862.1155
Advisory panel: Clinical Chemistry
Date received: 2017-09-01
Decision date: 2018-03-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shantou, CN

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.