The following data is part of a premarket notification filed by Mitsubishi Kagaku Iatron with the FDA for Pathfast D-dimer.
| Device ID | K072288 |
| 510k Number | K072288 |
| Device Name: | PATHFAST D-DIMER |
| Classification | Fibrin Split Products |
| 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 | GHH |
| CFR Regulation Number | 864.7320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-16 |
| Decision Date | 2009-05-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04987595301537 | K072288 | 000 |