Cleared Traditional

MINISTRIP/ SERUM AND URINE COMBO HCG TEST

K974060 · International Newtech Development, Inc. · Chemistry
Apr 1998
Decision
164d
Days
Class 2
Risk

About This 510(k) Submission

K974060 is an FDA 510(k) clearance for the MINISTRIP/ SERUM AND URINE COMBO HCG TEST, a Visual, Pregnancy Hcg, Prescription Use (Class II — Special Controls, product code JHI), submitted by International Newtech Development, Inc. (Delta, B.C., CA). The FDA issued a Cleared decision on April 9, 1998, 164 days after receiving the submission on October 27, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K974060 FDA.gov
FDA Decision Cleared SESE
Date Received October 27, 1997
Decision Date April 09, 1998
Days to Decision 164 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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