The following data is part of a premarket notification filed by Nuclear Diagnostics, Inc. with the FDA for Nuclitryp(tm)(i125)-human Pancrea Cath Try Rad Kit.
| Device ID | K932406 |
| 510k Number | K932406 |
| Device Name: | NUCLITRYP(TM)(I125)-HUMAN PANCREA CATH TRY RAD KIT |
| Classification | N-benzoyl-l-arginine Ethyl Ester (u.v.), Trypsin |
| Applicant | NUCLEAR DIAGNOSTICS, INC. 3322 COMMERCIAL AVE. Northbrook, IL 60062 |
| Contact | Joel Glovsky |
| Correspondent | Joel Glovsky NUCLEAR DIAGNOSTICS, INC. 3322 COMMERCIAL AVE. Northbrook, IL 60062 |
| Product Code | JNO |
| CFR Regulation Number | 862.1725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-05-13 |
| Decision Date | 1993-12-02 |