Cleared Traditional

K942853 - KOVA LIQUA-TROL

K942853 is the FDA 510(k) clearance for KOVA LIQUA-TROL by Hycor Biomedical, Inc.. It is a Class 1 Chemistry device (product code JJW) cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K942853 · Hycor Biomedical, Inc. · Chemistry device
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Oct 1994
Decision
110d
Days
Class 1
Risk

K942853 is an FDA 510(k) clearance for the KOVA LIQUA-TROL. Classified as Urinalysis Controls (assayed And Unassayed) (product code JJW), Class I - General Controls.

Submitted by Hycor Biomedical, Inc. (Garden Grove, US). The FDA issued a Cleared decision on October 4, 1994 after a review of 110 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Hycor Biomedical, Inc. devices

Submission Details

510(k) Number K942853 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 1994
Decision Date October 04, 1994
Days to Decision 110 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
22d slower than avg
Panel avg: 88d · This submission: 110d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJW Urinalysis 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 - JJW Urinalysis Controls (assayed And Unassayed)

All 35
Devices cleared under the same product code (JJW) and FDA review panel - the closest regulatory comparables to K942853.
URICHEMTRAK LIQUID ASSAYED CONTROL LEVELS 1 AND 2
K981933 · Medical Analysis Systems, Inc. · Jun 1998
MAS LIQUID URINALYSIS CONTROL LEVEL 1, LEVEL 2 AND LEVEL 3
K973451 · Medical Analysis Systems, Inc. · Sep 1997
NEGATIVE CONTROL STRIPS FOR URINALYSIS (CHEX-STIX, CLINITEK AUTO 2000, CLINITEX ATLAS)
K943780 · Heraeus Kulzer, Inc. · Oct 1994
MAS LIQUID URINALYSIS CONTROL
K935062 · Medical Analysis Systems, Inc. · Jan 1994
CHEK-STIX CONTROL STRIPS FOR URINALYSIS
K931467 · Heraeus Kulzer, Inc. · May 1993
BIOTROL CHEMISTRY URINE CONTROL
K891286 · Biotrol, USA, Inc. · Apr 1989