The following data is part of a premarket notification filed by Fisher Diagnostics with the FDA for Fisher Diagnostics Latest-crp Test Kit.
| Device ID | K850160 |
| 510k Number | K850160 |
| Device Name: | FISHER DIAGNOSTICS LATEST-CRP TEST KIT |
| Classification | C-reactive Protein, Antigen, Antiserum, And Control |
| Applicant | FISHER DIAGNOSTICS 526 ROUTE 303 Orangeburg, NY 10962 |
| Contact | Charles B Breuer |
| Correspondent | Charles B Breuer FISHER DIAGNOSTICS 526 ROUTE 303 Orangeburg, NY 10962 |
| Product Code | DCK |
| CFR Regulation Number | 866.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-01-15 |
| Decision Date | 1985-04-19 |