The following data is part of a premarket notification filed by Syn-kit, Inc. with the FDA for Crp Slide.
Device ID | K810862 |
510k Number | K810862 |
Device Name: | CRP SLIDE |
Classification | System, Test, C-reactive Protein |
Applicant | SYN-KIT, 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 | 1981-03-31 |
Decision Date | 1981-04-08 |