Cleared Traditional

K023551 - WIENER LAB GOT (AST) UV AA LIQUIDA

K023551 is an FDA 510(k) clearance for WIENER LAB GOT (AST) UV AA LIQUIDA, manufactured by Wiener Laboratories Saic. The device is a Class 2 Chemistry device with product code CIT cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K023551 · Wiener Laboratories Saic · Chemistry device
Download Printable Device Report (PDF)
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Dec 2002
Decision
48d
Days
Class 2
Risk

K023551 is an FDA 510(k) clearance for the WIENER LAB GOT (AST) UV AA LIQUIDA. Classified as Nadh Oxidation/nad Reduction, Ast/sgot (product code CIT), Class II - Special Controls.

Submitted by Wiener Laboratories Saic (Rosario, Santa Fe, AR). The FDA issued a Cleared decision on December 9, 2002 after a review of 48 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1100 - 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 Wiener Laboratories Saic devices

FDA 510(k) Submission Details - K023551

510(k) Number K023551 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 2002
Decision Date December 09, 2002
Days to Decision 48 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
40d faster than avg
Panel avg: 88d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CIT Device Classification - Class 2, Special Controls

Product Code CIT Nadh Oxidation/nad Reduction, Ast/sgot
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1100
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - CIT Nadh Oxidation/nad Reduction, Ast/sgot

All 116
Devices cleared under the same product code (CIT) and FDA review panel - the closest regulatory comparables to K023551.
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