Atlas FDA

JNO

7 FDA 510(k) clearances · Product code

130 daysmedian time to decision
281 days90th percentile
7clearances measured

FDA profile

Official device name
N-Benzoyl-L-Arginine Ethyl Ester (U.V.), Trypsin
Device class
Class I (low risk)
Regulation
21 CFR 862.1725
Medical specialty
Clinical Chemistry
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RecordFirmDate
AUTODELFIA NEONATAL IRT KIT (K110274)Wallac Oy, A Subsidiary of Perkinelmer, Inc.2011-06-10
GSP NEONATAL IRT KIT (3306-001U) (K102419)Wallac Oy, Subsidiary of Perkinelmer2010-12-16
NUCLITRYP(TM)(I125)-HUMAN PANCREA CATH TRY RAD KIT (K932406)Nuclear Diagnostics, Inc.1993-12-02
MRI NEO-TRYP TRYPSIN RIA (K883011)Microbiological Research Corp.1989-04-26
TRYPSIN RIA KIT (K861097)Microanalytic Research, Inc.1986-05-29
TRYPIN (125I) RIA KIT (K811805)Bd Becton Dickinson Vacutainer Systems Preanalytic1981-08-31
RIA KIT FOR TRYPSIN (K791202)Cis Radiopharmaceuticals, Inc.1979-11-05

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Every clearance here is in the API, with alerts when new ones post.