The following data is part of a premarket notification filed by Technicon Instruments Corp. with the FDA for C-reactive Protein (crp), For Technicon Ra Systems.
| Device ID | K863628 |
| 510k Number | K863628 |
| Device Name: | C-REACTIVE PROTEIN (CRP), FOR TECHNICON RA SYSTEMS |
| Classification | C-reactive Protein, Antigen, Antiserum, And Control |
| Applicant | TECHNICON INSTRUMENTS CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 |
| Contact | Leonard A Dwarica |
| Correspondent | Leonard A Dwarica TECHNICON INSTRUMENTS CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 |
| Product Code | DCK |
| CFR Regulation Number | 866.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-17 |
| Decision Date | 1986-10-15 |