Cleared Traditional

K932406 - NUCLITRYP(TM)(I125)-HUMAN PANCREA CATH TRY RAD KIT (FDA 510(k) Clearance)

Class I Chemistry device.

K932406 · Nuclear Diagnostics, Inc. · Chemistry device
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Dec 1993
Decision
203d
Days
Class 1
Risk

K932406 is an FDA 510(k) clearance for the NUCLITRYP(TM)(I125)-HUMAN PANCREA CATH TRY RAD KIT. Classified as N-benzoyl-l-arginine Ethyl Ester (u.v.), Trypsin (product code JNO), Class I - General Controls.

Submitted by Nuclear Diagnostics, Inc. (Northbrook, US). The FDA issued a Cleared decision on December 2, 1993 after a review of 203 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 Nuclear Diagnostics, Inc. devices

Submission Details

510(k) Number K932406 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 1993
Decision Date December 02, 1993
Days to Decision 203 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
115d slower than avg
Panel avg: 88d · This submission: 203d
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.