The following data is part of a premarket notification filed by Boditech Diagnostics, Inc. with the FDA for I-chroma Crp Test.
| Device ID | K062981 |
| 510k Number | K062981 |
| Device Name: | I-CHROMA CRP TEST |
| Classification | System, Test, C-reactive Protein |
| Applicant | BODITECH DIAGNOSTICS, INC. 150 CHERRY LANE RD. East Stroudsburg, PA 18301 |
| Contact | Gary Lehnus |
| Correspondent | Gary Lehnus BODITECH DIAGNOSTICS, INC. 150 CHERRY LANE RD. East Stroudsburg, PA 18301 |
| Product Code | DCN |
| CFR Regulation Number | 866.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-29 |
| Decision Date | 2007-07-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08806679001520 | K062981 | 000 |
| 08806133010099 | K062981 | 000 |