Cleared Traditional

TARGET(TM) QUANTITATIVE HCG

K890131 · V-Tech, Inc. · Chemistry
Mar 1989
Decision
56d
Days
Class 2
Risk

About This 510(k) Submission

K890131 is an FDA 510(k) clearance for the TARGET(TM) QUANTITATIVE HCG, a Visual, Pregnancy Hcg, Prescription Use (Class II — Special Controls, product code JHI), submitted by V-Tech, Inc. (El Monte, US). The FDA issued a Cleared decision on March 9, 1989, 56 days after receiving the submission on January 12, 1989. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K890131 FDA.gov
FDA Decision Cleared SESE
Date Received January 12, 1989
Decision Date March 09, 1989
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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