The following data is part of a premarket notification filed by American Bio Medica Corp. with the FDA for Rapidone-ecstasy Test.
| Device ID | K013180 |
| 510k Number | K013180 |
| Device Name: | RAPIDONE-ECSTASY TEST |
| Classification | Thin Layer Chromatography, Methamphetamine |
| Applicant | AMERICAN BIO MEDICA CORP. 9110 RED BRANCH RD. Columbia, MD 21045 |
| Contact | Henry Wells |
| Correspondent | Henry Wells AMERICAN BIO MEDICA CORP. 9110 RED BRANCH RD. Columbia, MD 21045 |
| Product Code | DJC |
| CFR Regulation Number | 862.3610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-09-24 |
| Decision Date | 2001-11-26 |
| Summary: | summary |