Cleared Traditional

OPTI-CHECK PLUS MULTI-ANALYTE CONTROL, MODEL HC7009

K001632 · Avl Scientific Corp. · Chemistry
Jun 2000
Decision
24d
Days
Class 1
Risk

About This 510(k) Submission

K001632 is an FDA 510(k) clearance for the OPTI-CHECK PLUS MULTI-ANALYTE CONTROL, MODEL HC7009, a Multi-analyte Controls, All Kinds (assayed) (Class I — General Controls, product code JJY), submitted by Avl Scientific Corp. (Roswell, US). The FDA issued a Cleared decision on June 19, 2000, 24 days after receiving the submission on May 26, 2000. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K001632 FDA.gov
FDA Decision Cleared SESE
Date Received May 26, 2000
Decision Date June 19, 2000
Days to Decision 24 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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