Cleared Traditional

K883011 - MRI NEO-TRYP TRYPSIN RIA (FDA 510(k) Clearance)

Class I Chemistry device.

K883011 · Microbiological Research Corp. · Chemistry device
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Apr 1989
Decision
281d
Days
Class 1
Risk

K883011 is an FDA 510(k) clearance for the MRI NEO-TRYP TRYPSIN RIA. Classified as N-benzoyl-l-arginine Ethyl Ester (u.v.), Trypsin (product code JNO), Class I - General Controls.

Submitted by Microbiological Research Corp. (Laguna Hills, US). The FDA issued a Cleared decision on April 26, 1989 after a review of 281 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1725 - 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 Microbiological Research Corp. devices

Submission Details

510(k) Number K883011 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 1988
Decision Date April 26, 1989
Days to Decision 281 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
193d slower than avg
Panel avg: 88d · This submission: 281d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JNO N-benzoyl-l-arginine Ethyl Ester (u.v.), Trypsin
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1725
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.