Cleared Traditional

K961941 - LIQUICHEK IMMUNOASSAY PLUS CONTROL CATALOG NO. 360,361,362,363

K961941 is an FDA 510(k) clearance for LIQUICHEK IMMUNOASSAY PLUS CONTROL CATA..., manufactured by Bio-Rad. The device is a Class 1 Chemistry device with product code JJY cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K961941 · Bio-Rad · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1996
Decision
119d
Days
Class 1
Risk

K961941 is an FDA 510(k) clearance for the LIQUICHEK IMMUNOASSAY PLUS CONTROL CATALOG NO. 360,361,362,363. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Bio-Rad (Anaheim, US). The FDA issued a Cleared decision on September 16, 1996 after a review of 119 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 Bio-Rad devices

FDA 510(k) Submission Details - K961941

510(k) Number K961941 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 1996
Decision Date September 16, 1996
Days to Decision 119 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
31d slower than avg
Panel avg: 88d · This submission: 119d
Pathway characteristics
Predicate-based equivalence.

JJY Device Classification - Class 1, General Controls

Product Code JJY Multi-analyte Controls, All Kinds (assayed)
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 - JJY Multi-analyte Controls, All Kinds (assayed)

All 595
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