Cleared Traditional

TARGET(TM) HOG ONE STEP

K903937 · V-Tech, Inc. · Chemistry
Oct 1990
Decision
56d
Days
Class 2
Risk

About This 510(k) Submission

K903937 is an FDA 510(k) clearance for the TARGET(TM) HOG ONE STEP, 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 22, 1990, 56 days after receiving the submission on August 27, 1990. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K903937 FDA.gov
FDA Decision Cleared SESE
Date Received August 27, 1990
Decision Date October 22, 1990
Days to Decision 56 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

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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