The following data is part of a premarket notification filed by Nano-ditech Corporation with the FDA for Nano-check Ami Ctni Cardiac Marker Test.
| Device ID | K102131 |
| 510k Number | K102131 |
| Device Name: | NANO-CHECK AMI CTNI CARDIAC MARKER TEST |
| Classification | Immunoassay Method, Troponin Subunit |
| Applicant | NANO-DITECH CORPORATION 7 CLARKE DRIVE SUITE 3 Cranbury, NJ 08512 |
| Contact | Young Hoon Kim |
| Correspondent | Young Hoon 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 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00895160002076 | K102131 | 000 |