Cleared Traditional

A1C-CELLULAR

K040025 · Streck Laboratories, Inc. · Chemistry
Mar 2004
Decision
55d
Days
Class 1
Risk

About This 510(k) Submission

K040025 is an FDA 510(k) clearance for the A1C-CELLULAR, a Single (specified) Analyte Controls (assayed And Unassayed) (Class I — General Controls, product code JJX), submitted by Streck Laboratories, Inc. (La Vista, US). The FDA issued a Cleared decision on March 2, 2004, 55 days after receiving the submission on January 7, 2004. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K040025 FDA.gov
FDA Decision Cleared SESE
Date Received January 07, 2004
Decision Date March 02, 2004
Days to Decision 55 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

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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