Cleared Traditional

AVL MODEL 987 ELECTROLYTE ANALYZER

K891578 · Avl Scientific Corp. · Chemistry
May 1989
Decision
63d
Days
Class 2
Risk

About This 510(k) Submission

K891578 is an FDA 510(k) clearance for the AVL MODEL 987 ELECTROLYTE ANALYZER, a Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph (Class II — Special Controls, product code CHL), submitted by Avl Scientific Corp. (Roswell, US). The FDA issued a Cleared decision on May 22, 1989, 63 days after receiving the submission on March 20, 1989. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1120.

Submission Details

510(k) Number K891578 FDA.gov
FDA Decision Cleared SESE
Date Received March 20, 1989
Decision Date May 22, 1989
Days to Decision 63 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code CHL — Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1120

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