Cleared Traditional

CHEM-CHEX STAT

K961195 · Streck Laboratories, Inc. · Chemistry
May 1996
Decision
49d
Days
Class 1
Risk

About This 510(k) Submission

K961195 is an FDA 510(k) clearance for the CHEM-CHEX STAT, a Multi-analyte Controls, All Kinds (assayed) (Class I — General Controls, product code JJY), submitted by Streck Laboratories, Inc. (Omaha, US). The FDA issued a Cleared decision on May 15, 1996, 49 days after receiving the submission on March 27, 1996. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K961195 FDA.gov
FDA Decision Cleared SESE
Date Received March 27, 1996
Decision Date May 15, 1996
Days to Decision 49 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JJY — Multi-analyte Controls, All Kinds (assayed)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1660

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