Cleared Traditional

TARGET HCG, ENZYME IMMUNOASSAY REAGENTS

K862247 · V-Tech, Inc. · Chemistry
Jul 1986
Decision
47d
Days
Class 2
Risk

About This 510(k) Submission

K862247 is an FDA 510(k) clearance for the TARGET HCG, ENZYME IMMUNOASSAY REAGENTS, 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 July 29, 1986, 47 days after receiving the submission on June 12, 1986. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K862247 FDA.gov
FDA Decision Cleared SESE
Date Received June 12, 1986
Decision Date July 29, 1986
Days to Decision 47 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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