The following data is part of a premarket notification filed by Clinical Sciences, Inc. with the FDA for Ndna Immunopath Fluoro-kit.
Device ID | K770057 |
510k Number | K770057 |
Device Name: | NDNA IMMUNOPATH FLUORO-KIT |
Classification | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control |
Applicant | CLINICAL SCIENCES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DHN |
CFR Regulation Number | 866.5100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1977-01-11 |
Decision Date | 1977-04-05 |