The following data is part of a premarket notification filed by Calbiochem-behring Corp. with the FDA for Aft Tm System Antismooth Muscle Antibody.
Device ID | K800820 |
510k Number | K800820 |
Device Name: | AFT TM SYSTEM ANTISMOOTH MUSCLE ANTIBODY |
Classification | Antismooth Muscle Antibody, Indirect Immunofluorescent, Antigen, Control |
Applicant | CALBIOCHEM-BEHRING CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DBE |
CFR Regulation Number | 866.5120 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-04-11 |
Decision Date | 1980-04-24 |