The following data is part of a premarket notification filed by Antibodies Inc. with the FDA for Crithidna Anti-dna Test Kit.
Device ID | K812314 |
510k Number | K812314 |
Device Name: | CRITHIDNA ANTI-DNA TEST KIT |
Classification | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control |
Applicant | ANTIBODIES 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 | 1981-08-17 |
Decision Date | 1981-09-01 |