Cleared Traditional

I-STAT(TM) LEVELS 1,2,3 CONTROLS

K921477 · I-Stat Corp. · Chemistry
Nov 1992
Decision
217d
Days
Class 1
Risk

About This 510(k) Submission

K921477 is an FDA 510(k) clearance for the I-STAT(TM) LEVELS 1,2,3 CONTROLS, a Multi-analyte Controls, All Kinds (assayed) (Class I — General Controls, product code JJY), submitted by I-Stat Corp. (Ontario K2l 1t9, Canada, CA). The FDA issued a Cleared decision on November 2, 1992, 217 days after receiving the submission on March 30, 1992. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K921477 FDA.gov
FDA Decision Cleared SESE
Date Received March 30, 1992
Decision Date November 02, 1992
Days to Decision 217 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

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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