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 |