The following data is part of a premarket notification filed by Nano-ditech Co. with the FDA for Nano-check Dat 5 Multi Drug Screening Test For Cannabinoids, Opiates, Cocaine, Methamphetamine & Phencyclidine.
| Device ID | K050594 |
| 510k Number | K050594 |
| Device Name: | NANO-CHECK DAT 5 MULTI DRUG SCREENING TEST FOR CANNABINOIDS, OPIATES, COCAINE, METHAMPHETAMINE & PHENCYCLIDINE |
| Classification | Enzyme Immunoassay, Cannabinoids |
| 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 | LDJ |
| Subsequent Product Code | DIO |
| Subsequent Product Code | DJC |
| Subsequent Product Code | DJG |
| Subsequent Product Code | LCM |
| CFR Regulation Number | 862.3870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-08 |
| Decision Date | 2005-05-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00895160002540 | K050594 | 000 |
| 00895160002533 | K050594 | 000 |
| 10895160002240 | K050594 | 000 |