Cleared Traditional

HUMAN CHORIONIC GONADOTROPIN CALIBRATOR

K970396 · Dade Chemistry Systems, Inc. · Chemistry
Feb 1997
Decision
17d
Days
Class 2
Risk

About This 510(k) Submission

K970396 is an FDA 510(k) clearance for the HUMAN CHORIONIC GONADOTROPIN CALIBRATOR, a Calibrator, Surrogate (Class II — Special Controls, product code JIW), submitted by Dade Chemistry Systems, Inc. (Glasgow, US). The FDA issued a Cleared decision on February 20, 1997, 17 days after receiving the submission on February 3, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1150.

Submission Details

510(k) Number K970396 FDA.gov
FDA Decision Cleared SESE
Date Received February 03, 1997
Decision Date February 20, 1997
Days to Decision 17 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JIW — Calibrator, Surrogate
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1150

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