The following data is part of a premarket notification filed by Nano-ditech Co. with the FDA for Nano-check Ami 3 In 1 Cardiac Disease Test For Cardiac Troponin I, Creatine Kinase Mb And Myoglobin.
| Device ID | K050975 |
| 510k Number | K050975 |
| Device Name: | NANO-CHECK AMI 3 IN 1 CARDIAC DISEASE TEST FOR CARDIAC TROPONIN I, CREATINE KINASE MB AND MYOGLOBIN |
| Classification | Immunoassay Method, Troponin Subunit |
| Applicant | NANO-DITECH CO. 55 Northern Blvd. Suite 200 Great Neck, NY 11021 |
| Contact | Susan D Goldstein-falk |
| Correspondent | Susan D Goldstein-falk NANO-DITECH CO. 55 Northern Blvd. Suite 200 Great Neck, NY 11021 |
| Product Code | MMI |
| Subsequent Product Code | DDR |
| Subsequent Product Code | JHT |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-04-18 |
| Decision Date | 2006-03-02 |
| Summary: | summary |