The following data is part of a premarket notification filed by Nano-ditech Corporation with the FDA for Nano-check Ami 2 In 1 Cardiac Marker, Ctnl And Myoglobin.
| Device ID | K102441 |
| 510k Number | K102441 |
| Device Name: | NANO-CHECK AMI 2 IN 1 CARDIAC MARKER, CTNL AND MYOGLOBIN |
| Classification | Immunoassay Method, Troponin Subunit |
| Applicant | NANO-DITECH CORPORATION 7 CLARKE DRIVE SUITE 3 Cranbury, NJ 08512 |
| Contact | Young Woo Kim |
| Correspondent | Young Woo Kim NANO-DITECH CORPORATION 7 CLARKE DRIVE SUITE 3 Cranbury, NJ 08512 |
| Product Code | MMI |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-29 |
| Decision Date | 2010-10-20 |