JNO · N-Benzoyl-L-Arginine Ethyl Ester (U.V.), Trypsin
Clinical Chemistry · 21 CFR 862.1725 · Class 1
Overview
| Product Code | JNO |
|---|---|
| Device Name | N-Benzoyl-L-Arginine Ethyl Ester (U.V.), Trypsin |
| Regulation | 21 CFR 862.1725 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
A trypsin test system is a device intended to measure the activity of trypsin (a pancreatic enzyme important in digestion for the breakdown of proteins) in blood and other body fluids and in feces. Measurements obtained by this device are used in the diagnosis and treatment of pancreatic disease.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
Cleared Devices (7)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K110274 | AUTODELFIA NEONATAL IRT KIT | Wallac Oy, A Subsidiary of Perkinelmer, Inc. | Jun 10, 2011 | SESE |
| K102419 | GSP NEONATAL IRT KIT (3306-001U) | Wallac Oy, Subsidiary of Perkinelmer | Dec 16, 2010 | SESE |
| K932406 | NUCLITRYP(TM)(I125)-HUMAN PANCREA CATH TRY RAD KIT | Nuclear Diagnostics, Inc. | Dec 2, 1993 | SESE |
| K883011 | MRI NEO-TRYP TRYPSIN RIA | Microbiological Research Corp. | Apr 26, 1989 | SESE |
| K861097 | TRYPSIN RIA KIT | Microanalytic Research, Inc. | May 29, 1986 | SESE |
| K811805 | TRYPIN (125I) RIA KIT | Bd Becton Dickinson Vacutainer Systems Preanalytic | Aug 31, 1981 | SESE |
| K791202 | RIA KIT FOR TRYPSIN | Cis Radiopharmaceuticals, Inc. | Nov 5, 1979 | SESE |
Top Applicants
- Wallac Oy, Subsidiary of Perkinelmer — 1 clearance
- Wallac Oy, A Subsidiary of Perkinelmer, Inc. — 1 clearance
- Nuclear Diagnostics, Inc. — 1 clearance
- Microbiological Research Corp. — 1 clearance
- Microanalytic Research, Inc. — 1 clearance
