The following data is part of a premarket notification filed by Diagnostic Technology, Inc. with the FDA for Crp-check.
Device ID | K831465 |
510k Number | K831465 |
Device Name: | CRP-CHECK |
Classification | System, Test, C-reactive Protein |
Applicant | DIAGNOSTIC TECHNOLOGY, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DCN |
CFR Regulation Number | 866.5270 [🔎] |
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 |
---|---|
CRP-CHECK 73430028 not registered Dead/Abandoned |
DIAGNOSTIC TECHNOLOGY INC. 1983-06-13 |