The following data is part of a premarket notification filed by Microanalytic Research, Inc. with the FDA for Trypsin Ria Kit.
| Device ID | K861097 |
| 510k Number | K861097 |
| Device Name: | TRYPSIN RIA KIT |
| Classification | N-benzoyl-l-arginine Ethyl Ester (u.v.), Trypsin |
| Applicant | MICROANALYTIC RESEARCH, INC. 23461 RIDGE ROUTE UNIT H Laguna Hills, CA 92653 |
| Contact | Jeffrey C Travis |
| Correspondent | Jeffrey C Travis MICROANALYTIC RESEARCH, INC. 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 | 1986-03-24 |
| Decision Date | 1986-05-29 |