The following data is part of a premarket notification filed by Immuno-products Industries with the FDA for Antinuclear Antibody Screen Flouresc.
Device ID | K821576 |
510k Number | K821576 |
Device Name: | ANTINUCLEAR ANTIBODY SCREEN FLOURESC |
Classification | Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control |
Applicant | IMMUNO-PRODUCTS INDUSTRIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DBL |
CFR Regulation Number | 866.5660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-05-28 |
Decision Date | 1982-06-10 |