The following data is part of a premarket notification filed by Mitsubishi Kagaku Iatron with the FDA for Pathfast Ntprobnp And D-dimer Tests.
| Device ID | K072189 |
| 510k Number | K072189 |
| Device Name: | PATHFAST NTPROBNP AND D-DIMER TESTS |
| Classification | Test, Natriuretic Peptide |
| 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 | NBC |
| CFR Regulation Number | 862.1117 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-06 |
| Decision Date | 2008-02-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04987595301636 | K072189 | 000 |