N-Benzoyl-L-Arginine Ethyl Ester (U.V.), Trypsin
The N-Benzoyl-L-Arginine Ethyl Ester (U.V.), Trypsin test is a clinical chemistry diagnostic reagent used to measure trypsin activity using the synthetic substrate BAEE, which is hydrolyzed by trypsin and quantified by ultraviolet spectrophotometric measurement of the resulting product. This assay supports investigation of pancreatic function. This device is FDA Class 1, the lowest risk category, requiring only general controls and no premarket notification. It carries product code JNO and is regulated under 21 CFR 862.1725, within the Clinical Chemistry medical specialty.
Research product code JNO in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- JNO
- Device Class
- FDA class 1
- Regulation Number
- 862.1725
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 7 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K110274 | AUTODELFIA NEONATAL IRT KIT | Jun 10, 2011 | Substantially Equivalent | Wallac Oy, A Subsidiary of Perkinelmer, Inc. |
| K102419 | GSP NEONATAL IRT KIT (3306-001U) | Dec 16, 2010 | Substantially Equivalent | Wallac Oy, Subsidiary of Perkinelmer |
| K932406 | NUCLITRYP(TM)(I125)-HUMAN PANCREA CATH TRY RAD KIT | Dec 02, 1993 | Substantially Equivalent | Nuclear Diagnostics, Inc. |
| K883011 | MRI NEO-TRYP TRYPSIN RIA | Apr 26, 1989 | Substantially Equivalent | Microbiological Research Corp. |
| K861097 | TRYPSIN RIA KIT | May 29, 1986 | Substantially Equivalent | Microanalytic Research, Inc. |
| K811805 | TRYPIN (125I) RIA KIT | Aug 31, 1981 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K791202 | RIA KIT FOR TRYPSIN | Nov 05, 1979 | Substantially Equivalent | Cis Radiopharmaceuticals, Inc. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.