Cleared Traditional

MRI NEO-TRYP TRYPSIN RIA

K883011 · Microbiological Research Corp. · Chemistry
Apr 1989
Decision
281d
Days
Class 1
Risk

About This 510(k) Submission

K883011 is an FDA 510(k) clearance for the MRI NEO-TRYP TRYPSIN RIA, a N-benzoyl-l-arginine Ethyl Ester (u.v.), Trypsin (Class I — General Controls, product code JNO), submitted by Microbiological Research Corp. (Laguna Hills, US). The FDA issued a Cleared decision on April 26, 1989, 281 days after receiving the submission on July 19, 1988. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1725.

Submission Details

510(k) Number K883011 FDA.gov
FDA Decision Cleared SESE
Date Received July 19, 1988
Decision Date April 26, 1989
Days to Decision 281 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

Similar Devices — JNO N-benzoyl-l-arginine Ethyl Ester (u.v.), Trypsin

AUTODELFIA NEONATAL IRT KIT
K110274 · Wallac Oy, A Subsidiary of Perkinelmer, Inc. · Jun 2011
GSP NEONATAL IRT KIT (3306-001U)
K102419 · Wallac Oy, Subsidiary of Perkinelmer · Dec 2010
NUCLITRYP(TM)(I125)-HUMAN PANCREA CATH TRY RAD KIT
K932406 · Nuclear Diagnostics, Inc. · Dec 1993
TRYPSIN RIA KIT
K861097 · Microanalytic Research, Inc. · May 1986
TRYPIN (125I) RIA KIT
K811805 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1981
RIA KIT FOR TRYPSIN
K791202 · Cis Radiopharmaceuticals, Inc. · Nov 1979