Cleared Traditional

TRYPSIN RIA KIT

K861097 · Microanalytic Research, Inc. · Chemistry
May 1986
Decision
66d
Days
Class 1
Risk

About This 510(k) Submission

K861097 is an FDA 510(k) clearance for the TRYPSIN RIA KIT, a N-benzoyl-l-arginine Ethyl Ester (u.v.), Trypsin (Class I — General Controls, product code JNO), submitted by Microanalytic Research, Inc. (Laguna Hills, US). The FDA issued a Cleared decision on May 29, 1986, 66 days after receiving the submission on March 24, 1986. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1725.

Submission Details

510(k) Number K861097 FDA.gov
FDA Decision Cleared SESE
Date Received March 24, 1986
Decision Date May 29, 1986
Days to Decision 66 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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