Cleared Traditional

K952637 - QUALICHECK 4 GLUCOSE

K952637 is an FDA 510(k) clearance for QUALICHECK 4 GLUCOSE, manufactured by Radiometer America, Inc.. The device is a Class 1 Chemistry device with product code JJS cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K952637 · Radiometer America, Inc. · Chemistry device
Download Printable Device Report (PDF)
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Sep 1995
Decision
88d
Days
Class 1
Risk

K952637 is an FDA 510(k) clearance for the QUALICHECK 4 GLUCOSE. Classified as Controls For Blood-gases, (assayed And Unassayed) (product code JJS), Class I - General Controls.

Submitted by Radiometer America, Inc. (Westlake, US). The FDA issued a Cleared decision on September 5, 1995 after a review of 88 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 Radiometer America, Inc. devices

FDA 510(k) Submission Details - K952637

510(k) Number K952637 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 1995
Decision Date September 05, 1995
Days to Decision 88 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 88d · This submission: 88d
Pathway characteristics
Predicate-based equivalence.

JJS Device Classification - Class 1, General Controls

Product Code JJS Controls For Blood-gases, (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 - JJS Controls For Blood-gases, (assayed And Unassayed)

All 57
Devices cleared under the same product code (JJS) and FDA review panel - the closest regulatory comparables to K952637.
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