The following data is part of a premarket notification filed by Cis Radiopharmaceuticals, Inc. with the FDA for Ria Kit For Trypsin.
Device ID | K791202 |
510k Number | K791202 |
Device Name: | RIA KIT FOR TRYPSIN |
Classification | N-benzoyl-l-arginine Ethyl Ester (u.v.), Trypsin |
Applicant | CIS RADIOPHARMACEUTICALS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JNO |
CFR Regulation Number | 862.1725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-06-28 |
Decision Date | 1979-11-05 |