The following data is part of a premarket notification filed by Johnson & Johnson Clinical Diagnostics, Inc. with the FDA for Ektachem Clinical Chemistry Slide C-reactive Protein (crp).
| Device ID | K953197 |
| 510k Number | K953197 |
| Device Name: | EKTACHEM CLINICAL CHEMISTRY SLIDE C-REACTIVE PROTEIN (CRP) |
| Classification | C-reactive Protein, Antigen, Antiserum, And Control |
| Applicant | JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. 100 INDIGO CREEK DR. Rochester, NY 14650 -0882 |
| Contact | Yvonne E Middlefell |
| Correspondent | Yvonne E Middlefell JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. 100 INDIGO CREEK DR. Rochester, NY 14650 -0882 |
| Product Code | DCK |
| CFR Regulation Number | 866.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-10 |
| Decision Date | 1995-07-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10758750005208 | K953197 | 000 |
| 10758750005062 | K953197 | 000 |