The following data is part of a premarket notification filed by Immuno-diagnostic Products, Inc. with the FDA for Rf-ii Test Kit.
Device ID | K801961 |
510k Number | K801961 |
Device Name: | RF-II TEST KIT |
Classification | System, Test, Rheumatoid Factor |
Applicant | IMMUNO-DIAGNOSTIC PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DHR |
CFR Regulation Number | 866.5775 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-08-19 |
Decision Date | 1980-10-10 |