FDA product code JNO: N-Benzoyl-L-Arginine Ethyl Ester (U.V.), Trypsin
JNO is the FDA product code for n-benzoyl-l-arginine ethyl ester (u.v.), trypsin. It is a Class I device, regulated under 21 CFR 862.1725 and reviewed by the Clinical Chemistry panel. FDA has cleared 7 510(k) submissions under JNO, from 7 different applicants. The average 510(k) review took 142 days (median 130). FDA has posted 2 recalls for JNO devices.
Classification
| Field | Value |
|---|---|
| Device name | N-Benzoyl-L-Arginine Ethyl Ester (U.V.), Trypsin |
| Device class | Class I |
| Regulation | 21 CFR 862.1725 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JNO clearance
Top JNO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Wallac Oy, A Subsidiary of Perkinelmer, Inc. | 1 | 2011-06-10 |
| Wallac Oy, Subsidiary of Perkinelmer | 1 | 2010-12-16 |
| Nuclear Diagnostics, Inc. | 1 | 1993-12-02 |
| Microbiological Research Corp. | 1 | 1989-04-26 |
| Microanalytic Research, Inc. | 1 | 1986-05-29 |
2 more applicants have JNO clearances. See the full list in Caduvo.
Most recent JNO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K110274 | Wallac Oy, A Subsidiary of Perkinelmer, Inc. | AUTODELFIA NEONATAL IRT KIT | 2011-06-10 | 130 |
| K102419 | Wallac Oy, Subsidiary of Perkinelmer | GSP NEONATAL IRT KIT (3306-001U) | 2010-12-16 | 113 |
| K932406 | Nuclear Diagnostics, Inc. | NUCLITRYP(TM)(I125)-HUMAN PANCREA CATH TRY RAD KIT | 1993-12-02 | 203 |
| K883011 | Microbiological Research Corp. | MRI NEO-TRYP TRYPSIN RIA | 1989-04-26 | 281 |
| K861097 | Microanalytic Research, Inc. | TRYPSIN RIA KIT | 1986-05-29 | 66 |
Recalls for JNO devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2017-09-25.
| Year | Recalls |
|---|---|
| 2017 | 1 |
Frequently asked questions
What is FDA product code JNO?
JNO is the FDA product code for n-benzoyl-l-arginine ethyl ester (u.v.), trypsin. It is a Class I device, regulated under 21 CFR 862.1725 and reviewed by the Clinical Chemistry panel.
What device class is JNO?
Class I, regulation 21 CFR 862.1725. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JNO?
Across 7 cleared submissions the average was 142 days from receipt to decision (median 130).
Which companies have the most JNO clearances?
Wallac Oy, A Subsidiary of Perkinelmer, Inc. (1); Wallac Oy, Subsidiary of Perkinelmer (1); Nuclear Diagnostics, Inc. (1); Microbiological Research Corp. (1); Microanalytic Research, Inc. (1).
Have JNO devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2017-09-25.
Next steps
- Run an FDA pathway report with predicate devices for product code JNO
- Run a recall and safety report across every JNO manufacturer
- Watch product code JNO for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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