The following data is part of a premarket notification filed by Diagnostic Technology, Inc. with the FDA for Ra-check.
Device ID | K831467 |
510k Number | K831467 |
Device Name: | RA-CHECK |
Classification | System, Test, Rheumatoid Factor |
Applicant | DIAGNOSTIC TECHNOLOGY, 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 | 1983-05-06 |
Decision Date | 1983-06-08 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
RA-CHECK 73430029 1281044 Dead/Cancelled |
Diagnostic Technology Inc. 1983-06-13 |