Cleared Traditional

TARGET(TM)-HOG

K914303 · V-Tech, Inc. · Chemistry
Oct 1991
Decision
16d
Days
Class 2
Risk

About This 510(k) Submission

K914303 is an FDA 510(k) clearance for the TARGET(TM)-HOG, a Visual, Pregnancy Hcg, Prescription Use (Class II — Special Controls, product code JHI), submitted by V-Tech, Inc. (Pomona, US). The FDA issued a Cleared decision on October 11, 1991, 16 days after receiving the submission on September 25, 1991. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K914303 FDA.gov
FDA Decision Cleared SESE
Date Received September 25, 1991
Decision Date October 11, 1991
Days to Decision 16 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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