The following data is part of a premarket notification filed by Pointe Scientific, Inc. with the FDA for C-reactive Protein (high Sensitivity) Reagent Set.
| Device ID | K002651 |
| 510k Number | K002651 |
| Device Name: | C-REACTIVE PROTEIN (HIGH SENSITIVITY) REAGENT SET |
| Classification | C-reactive Protein, Antigen, Antiserum, And Control |
| Applicant | POINTE SCIENTIFIC, INC. 1025 JOHN A. PAPALAS DR. Lincoln Park, MI 48146 |
| Contact | Ron Jamison |
| Correspondent | Ron Jamison POINTE SCIENTIFIC, INC. 1025 JOHN A. PAPALAS DR. Lincoln Park, MI 48146 |
| Product Code | DCK |
| CFR Regulation Number | 866.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-25 |
| Decision Date | 2000-10-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811727011060 | K002651 | 000 |
| 00817302022100 | K002651 | 000 |
| 00817274021477 | K002651 | 000 |
| 00817274021361 | K002651 | 000 |