The following data is part of a premarket notification filed by Mitsubishi Kagaku Iatron with the FDA for Pathfast Ck-mb-ii, Pathfast Myo-ii.
| Device ID | K081360 |
| 510k Number | K081360 |
| Device Name: | PATHFAST CK-MB-II, PATHFAST MYO-II |
| Classification | Fluorometric Method, Cpk Or Isoenzymes |
| 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 | JHX |
| Subsequent Product Code | DDR |
| Subsequent Product Code | JIT |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-05-15 |
| Decision Date | 2009-08-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04987595301339 | K081360 | 000 |
| 04987595301230 | K081360 | 000 |