Cleared Traditional

EZ-HCG URINE(PREGNANCY TEST)

K003856 · Biomerica, Inc. · Chemistry
Feb 2001
Decision
70d
Days
Class 2
Risk

About This 510(k) Submission

K003856 is an FDA 510(k) clearance for the EZ-HCG URINE(PREGNANCY TEST), a Visual, Pregnancy Hcg, Prescription Use (Class II — Special Controls, product code JHI), submitted by Biomerica, Inc. (Newport Beach, US). The FDA issued a Cleared decision on February 21, 2001, 70 days after receiving the submission on December 13, 2000. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K003856 FDA.gov
FDA Decision Cleared SESE
Date Received December 13, 2000
Decision Date February 21, 2001
Days to Decision 70 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JHI — Visual, Pregnancy Hcg, Prescription Use
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1155

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