The following data is part of a premarket notification filed by Microbiological Research Corp. with the FDA for Mri Neo-tryp Trypsin Ria.
| Device ID | K883011 |
| 510k Number | K883011 |
| Device Name: | MRI NEO-TRYP TRYPSIN RIA |
| Classification | N-benzoyl-l-arginine Ethyl Ester (u.v.), Trypsin |
| Applicant | MICROBIOLOGICAL RESEARCH CORP. 23461 RIDGE ROUTE UNIT H Laguna Hills, CA 92653 |
| Contact | C Travis,phd |
| Correspondent | C Travis,phd MICROBIOLOGICAL RESEARCH CORP. 23461 RIDGE ROUTE UNIT H Laguna Hills, CA 92653 |
| Product Code | JNO |
| CFR Regulation Number | 862.1725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-07-19 |
| Decision Date | 1989-04-26 |