Cleared Traditional

TRYPIN (125I) RIA KIT

K811805 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Chemistry
Aug 1981
Decision
68d
Days
Class 1
Risk

About This 510(k) Submission

K811805 is an FDA 510(k) clearance for the TRYPIN (125I) RIA KIT, a N-benzoyl-l-arginine Ethyl Ester (u.v.), Trypsin (Class I — General Controls, product code JNO), submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on August 31, 1981, 68 days after receiving the submission on June 24, 1981. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1725.

Submission Details

510(k) Number K811805 FDA.gov
FDA Decision Cleared SESE
Date Received June 24, 1981
Decision Date August 31, 1981
Days to Decision 68 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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