The following data is part of a premarket notification filed by Mitsubishi Chemical Medience Corporation with the FDA for Pathfast Ctnl Calibrators.
| Device ID | K130603 |
| 510k Number | K130603 |
| Device Name: | PATHFAST CTNL CALIBRATORS |
| Classification | Calibrator, Secondary |
| Applicant | MITSUBISHI CHEMICAL MEDIENCE CORPORATION 2 BETHESDA METRO CENTER SUITE 850 Bethesda, MD 20814 |
| Contact | Judi Smith |
| Correspondent | Judi Smith MITSUBISHI CHEMICAL MEDIENCE CORPORATION 2 BETHESDA METRO CENTER SUITE 850 Bethesda, MD 20814 |
| Product Code | JIT |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-07 |
| Decision Date | 2014-03-27 |
| Summary: | summary |