Cleared Traditional

K934641 - I-STAT CONTROL LEVELS 1

K934641 is the FDA 510(k) clearance for I-STAT CONTROL LEVELS 1 by I-Stat Corp.. It is a Class 1 Chemistry device (product code JJR) cleared through the Traditional 510(k) pathway after a 79-day FDA review.

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

K934641 is an FDA 510(k) clearance for the I-STAT CONTROL LEVELS 1,2,3. Classified as Electrolyte Controls (assayed And Unassayed) (product code JJR), Class I - General Controls.

Submitted by I-Stat Corp. (Princeton, US). The FDA issued a Cleared decision on December 9, 1993 after a review of 79 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1660 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all I-Stat Corp. devices

Submission Details

510(k) Number K934641 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 88d · This submission: 79d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJR Electrolyte Controls (assayed And Unassayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JJR Electrolyte Controls (assayed And Unassayed)

All 9
Devices cleared under the same product code (JJR) and FDA review panel - the closest regulatory comparables to K934641.
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