Cleared Traditional

I-STAT CONTROL LEVELS 1,2,3

K934641 · I-Stat Corp. · Chemistry
Dec 1993
Decision
79d
Days
Class 1
Risk

About This 510(k) Submission

K934641 is an FDA 510(k) clearance for the I-STAT CONTROL LEVELS 1,2,3, a Electrolyte Controls (assayed And Unassayed) (Class I — General Controls, product code JJR), submitted by I-Stat Corp. (Princeton, US). The FDA issued a Cleared decision on December 9, 1993, 79 days after receiving the submission on September 21, 1993. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K934641 FDA.gov
FDA Decision Cleared SESE
Date Received September 21, 1993
Decision Date December 09, 1993
Days to Decision 79 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JJR — Electrolyte Controls (assayed And Unassayed)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1660

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