The following data is part of a premarket notification filed by Immuno-diagnostic Products, Inc. with the FDA for Anti-ds/n-dna Test Kit.
Device ID | K801960 |
510k Number | K801960 |
Device Name: | ANTI-DS/N-DNA TEST KIT |
Classification | Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control |
Applicant | IMMUNO-DIAGNOSTIC PRODUCTS, INC. 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 | 1980-08-19 |
Decision Date | 1980-10-10 |