Cleared Traditional

RIA KIT FOR TRYPSIN

K791202 · Cis Radiopharmaceuticals, Inc. · Chemistry
Nov 1979
Decision
130d
Days
Class 1
Risk

About This 510(k) Submission

K791202 is an FDA 510(k) clearance for the RIA KIT FOR TRYPSIN, a N-benzoyl-l-arginine Ethyl Ester (u.v.), Trypsin (Class I — General Controls, product code JNO), submitted by Cis Radiopharmaceuticals, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 5, 1979, 130 days after receiving the submission on June 28, 1979. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1725.

Submission Details

510(k) Number K791202 FDA.gov
FDA Decision Cleared SESE
Date Received June 28, 1979
Decision Date November 05, 1979
Days to Decision 130 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

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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