Cleared Traditional

K932162 - URIC ACID TEST ITEM NUMBER 65422

K932162 is an FDA 510(k) clearance for URIC ACID TEST ITEM NUMBER 65422, manufactured by Em Diagnostic Systems, Inc.. The device is a Class 1 Chemistry device with product code CDO cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K932162 · Em Diagnostic Systems, Inc. · Chemistry device
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Sep 1993
Decision
146d
Days
Class 1
Risk

K932162 is an FDA 510(k) clearance for the URIC ACID TEST ITEM NUMBER 65422. Classified as Acid, Uric, Uricase (u.v.) (product code CDO), Class I - General Controls.

Submitted by Em Diagnostic Systems, Inc. (Gibbstown, US). The FDA issued a Cleared decision on September 27, 1993 after a review of 146 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1775 - 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 Em Diagnostic Systems, Inc. devices

FDA 510(k) Submission Details - K932162

510(k) Number K932162 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 1993
Decision Date September 27, 1993
Days to Decision 146 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d slower than avg
Panel avg: 88d · This submission: 146d
Pathway characteristics
Predicate-based equivalence.

CDO Device Classification - Class 1, General Controls

Product Code CDO Acid, Uric, Uricase (u.v.)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1775
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 - CDO Acid, Uric, Uricase (u.v.)

All 26
Devices cleared under the same product code (CDO) and FDA review panel - the closest regulatory comparables to K932162.
URIC ACID
K981189 · Abbott Laboratories · May 1998
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K971485 · Trace America, Inc. · May 1997
OLYMPUS URIC ACID REAGENT
K955752 · Olympus America, Inc. · Jan 1996
SYSTEMATE URICACID TEST, TECHNICON RA 1000
K923765 · Em Diagnostic Systems, Inc. · Sep 1992
SYSTEMATE URIC ACID (URCA) ITEM NUMBER 65422
K903335 · Em Diagnostic Systems, Inc. · Aug 1990
BIOTROL URIC ACID ENZYMATIQUE UV H.P.
K875320 · Biotrol, USA, Inc. · Feb 1988