Cleared Traditional

CLEARVIEW EASY HCG PREGNANCY TEST

K993703 · Unipath , Ltd. · Chemistry
Dec 1999
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K993703 is an FDA 510(k) clearance for the CLEARVIEW EASY HCG PREGNANCY TEST, a Visual, Pregnancy Hcg, Prescription Use (Class II — Special Controls, product code JHI), submitted by Unipath , Ltd. (Bedford, GB). The FDA issued a Cleared decision on December 2, 1999, 30 days after receiving the submission on November 2, 1999. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K993703 FDA.gov
FDA Decision Cleared SESE
Date Received November 02, 1999
Decision Date December 02, 1999
Days to Decision 30 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

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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