The following data is part of a premarket notification filed by Immuno-products Industries with the FDA for Antismooth Muscle Antibody Test Sys.
Device ID | K810983 |
510k Number | K810983 |
Device Name: | ANTISMOOTH MUSCLE ANTIBODY TEST SYS |
Classification | Antismooth Muscle Antibody, Indirect Immunofluorescent, Antigen, Control |
Applicant | IMMUNO-PRODUCTS INDUSTRIES 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 | 1981-04-13 |
Decision Date | 1981-05-01 |