The following data is part of a premarket notification filed by Stanbio Laboratory with the FDA for Wide Range C-reactive Protein (wr Crp) Assay.
| Device ID | K041155 |
| 510k Number | K041155 |
| Device Name: | WIDE RANGE C-REACTIVE PROTEIN (WR CRP) ASSAY |
| Classification | C-reactive Protein, Antigen, Antiserum, And Control |
| Applicant | STANBIO LABORATORY 1261 NORTH MAIN ST. Boerne, TX 78006 |
| Contact | Adaobi Oguchi |
| Correspondent | Adaobi Oguchi STANBIO LABORATORY 1261 NORTH MAIN ST. Boerne, TX 78006 |
| Product Code | DCK |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JIX |
| CFR Regulation Number | 866.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-05-03 |
| Decision Date | 2004-10-14 |