Cleared Traditional

PS-UNIT CASSETTE/SERUM AND URINE COMBO HCG

K974009 · International Newtech Development, Inc. · Chemistry
Mar 1998
Decision
143d
Days
Class 2
Risk

About This 510(k) Submission

K974009 is an FDA 510(k) clearance for the PS-UNIT CASSETTE/SERUM AND URINE COMBO HCG, 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 March 13, 1998, 143 days after receiving the submission on October 21, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K974009 FDA.gov
FDA Decision Cleared SESE
Date Received October 21, 1997
Decision Date March 13, 1998
Days to Decision 143 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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