Cleared Traditional

K021334 - WIENER LAB. CA-COLOR ARSENAZO III AA

K021334 is an FDA 510(k) clearance for WIENER LAB. CA-COLOR ARSENAZO III AA, manufactured by Wiener Laboratories Saic. The device is a Class 2 Chemistry device with product code CJY cleared through the Traditional 510(k) pathway after a 137-day FDA review.

K021334 · Wiener Laboratories Saic · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2002
Decision
137d
Days
Class 2
Risk

K021334 is an FDA 510(k) clearance for the WIENER LAB. CA-COLOR ARSENAZO III AA, MODEL 4X50 ML CAT.NR. 1152004, WIENER L.... Classified as Azo Dye, Calcium (product code CJY), Class II - Special Controls.

Submitted by Wiener Laboratories Saic (Rosario, Santa Fe, AR). The FDA issued a Cleared decision on September 10, 2002 after a review of 137 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1145 - 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 Wiener Laboratories Saic devices

FDA 510(k) Submission Details - K021334

510(k) Number K021334 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 2002
Decision Date September 10, 2002
Days to Decision 137 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
49d slower than avg
Panel avg: 88d · This submission: 137d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CJY Device Classification - Class 2, Special Controls

Product Code CJY Azo Dye, Calcium
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1145
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 - CJY Azo Dye, Calcium

All 34
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