The following data is part of a premarket notification filed by Diagnostic Chemicals Ltd. with the FDA for Crp-advance Assay, Models 250-20, 250-25.
| Device ID | K060139 |
| 510k Number | K060139 |
| Device Name: | CRP-ADVANCE ASSAY, MODELS 250-20, 250-25 |
| Classification | C-reactive Protein, Antigen, Antiserum, And Control |
| Applicant | DIAGNOSTIC CHEMICALS LTD. 16 MCCARVILLE ST. Charlottetown, Pe, CA C1e 2a6 |
| Contact | Penny White |
| Correspondent | Penny White DIAGNOSTIC CHEMICALS LTD. 16 MCCARVILLE ST. Charlottetown, Pe, CA C1e 2a6 |
| Product Code | DCK |
| CFR Regulation Number | 866.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-01-19 |
| Decision Date | 2006-04-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00628063400430 | K060139 | 000 |
| 00628063400041 | K060139 | 000 |