Cleared Traditional

CHEM-CHEX STAT (NEW)

K982290 · Streck Laboratories, Inc. · Chemistry
Jul 1998
Decision
23d
Days
Class 1
Risk

About This 510(k) Submission

K982290 is an FDA 510(k) clearance for the CHEM-CHEX STAT (NEW), 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 July 22, 1998, 23 days after receiving the submission on June 29, 1998. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K982290 FDA.gov
FDA Decision Cleared SESE
Date Received June 29, 1998
Decision Date July 22, 1998
Days to Decision 23 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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