Cleared Traditional

HCG CONTROLS

K970176 · International Newtech Development, Inc. · Chemistry
Feb 1997
Decision
20d
Days
Class 1
Risk

About This 510(k) Submission

K970176 is an FDA 510(k) clearance for the HCG CONTROLS, a Single (specified) Analyte Controls (assayed And Unassayed) (Class I — General Controls, product code JJX), submitted by International Newtech Development, Inc. (Richmond, B.C., CA). The FDA issued a Cleared decision on February 6, 1997, 20 days after receiving the submission on January 17, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K970176 FDA.gov
FDA Decision Cleared SESE
Date Received January 17, 1997
Decision Date February 06, 1997
Days to Decision 20 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JJX — Single (specified) Analyte Controls (assayed And Unassayed)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1660

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