Cleared Traditional

NUCLITRYP(TM)(I125)-HUMAN PANCREA CATH TRY RAD KIT

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

About This 510(k) Submission

K932406 is an FDA 510(k) clearance for the NUCLITRYP(TM)(I125)-HUMAN PANCREA CATH TRY RAD KIT, a N-benzoyl-l-arginine Ethyl Ester (u.v.), Trypsin (Class I — General Controls, product code JNO), submitted by Nuclear Diagnostics, Inc. (Northbrook, US). The FDA issued a Cleared decision on December 2, 1993, 203 days after receiving the submission on May 13, 1993. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1725.

Submission Details

510(k) Number K932406 FDA.gov
FDA Decision Cleared 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

Device Classification

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

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