The following data is part of a premarket notification filed by Mitsubishi Kagaku Iatron with the FDA for Pathfast Hscrp.
| Device ID | K083412 |
| 510k Number | K083412 |
| Device Name: | PATHFAST HSCRP |
| Classification | System, Test, C-reactive Protein |
| Applicant | MITSUBISHI KAGAKU IATRON 701 FIFTH AVENUE FLOOR 42 Seattle, WA 98104 |
| Contact | Helen Landicho |
| Correspondent | Helen Landicho MITSUBISHI KAGAKU IATRON 701 FIFTH AVENUE FLOOR 42 Seattle, WA 98104 |
| Product Code | DCN |
| CFR Regulation Number | 866.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-18 |
| Decision Date | 2009-03-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04987595301742 | K083412 | 000 |