Cleared Traditional

K861202 - TRU-LEVEL CONTROL IMMUNOASSAY CONTROLS

K861202 is the FDA 510(k) clearance for TRU-LEVEL CONTROL IMMUNOASSAY CONTROLS by Nms Pharmaceuticals, Inc.. It is a Class 1 Chemistry device (product code JJY) cleared through the Traditional 510(k) pathway after a 284-day FDA review.

K861202 · Nms Pharmaceuticals, Inc. · Chemistry device
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Jan 1987
Decision
284d
Days
Class 1
Risk

K861202 is an FDA 510(k) clearance for the TRU-LEVEL CONTROL IMMUNOASSAY CONTROLS. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Nms Pharmaceuticals, Inc. (Newport Beach, US). The FDA issued a Cleared decision on January 9, 1987 after a review of 284 days - an extended review cycle.

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 Nms Pharmaceuticals, Inc. devices

Submission Details

510(k) Number K861202 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 1986
Decision Date January 09, 1987
Days to Decision 284 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
196d slower than avg
Panel avg: 88d · This submission: 284d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 475
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