The following data is part of a premarket notification filed by Polymedco, Inc. with the FDA for C-reactive Protein (crp) Agglutination Latex Kit.
| Device ID | K962049 |
| 510k Number | K962049 |
| Device Name: | C-REACTIVE PROTEIN (CRP) AGGLUTINATION LATEX KIT |
| Classification | C-reactive Protein, Antigen, Antiserum, And Control |
| Applicant | POLYMEDCO, INC. 510 FURNACE DOCK RD. Cortlandt Manor, NY 10567 |
| Contact | John H Olsen |
| Correspondent | John H Olsen POLYMEDCO, INC. 510 FURNACE DOCK RD. Cortlandt Manor, NY 10567 |
| Product Code | DCK |
| CFR Regulation Number | 866.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-28 |
| Decision Date | 1996-12-18 |