Cleared Traditional

AVL OPTI-CHECK PH/ BLOOD GAS/ ELECTROLYTE/THB/ SO2 CONTROL

K974822 · Avl Scientific Corp. · Chemistry
Jan 1998
Decision
29d
Days
Class 1
Risk

About This 510(k) Submission

K974822 is an FDA 510(k) clearance for the AVL OPTI-CHECK PH/ BLOOD GAS/ ELECTROLYTE/THB/ SO2 CONTROL, 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 January 22, 1998, 29 days after receiving the submission on December 24, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K974822 FDA.gov
FDA Decision Cleared SESE
Date Received December 24, 1997
Decision Date January 22, 1998
Days to Decision 29 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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