Cleared Traditional

MINISTRIP HCG

K951705 · International Newtech Development, Inc. · Chemistry
Oct 1995
Decision
172d
Days
Class 2
Risk

About This 510(k) Submission

K951705 is an FDA 510(k) clearance for the MINISTRIP HCG, a Visual, Pregnancy Hcg, Prescription Use (Class II — Special Controls, product code JHI), submitted by International Newtech Development, Inc. (Richmond, B.C., CA). The FDA issued a Cleared decision on October 3, 1995, 172 days after receiving the submission on April 14, 1995. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K951705 FDA.gov
FDA Decision Cleared SESE
Date Received April 14, 1995
Decision Date October 03, 1995
Days to Decision 172 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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