The following data is part of a premarket notification filed by Psychemedics Corp. with the FDA for Psychemedics Analysis Of Morphine In Hair.
| Device ID | K000851 |
| 510k Number | K000851 |
| Device Name: | PSYCHEMEDICS ANALYSIS OF MORPHINE IN HAIR |
| Classification | Enzyme Immunoassay, Opiates |
| Applicant | PSYCHEMEDICS CORP. 1280 MASSACHUSETTS AVE. SUITE 200 Cambridge, MA 02138 |
| Contact | William Thistle |
| Correspondent | William Thistle PSYCHEMEDICS CORP. 1280 MASSACHUSETTS AVE. SUITE 200 Cambridge, MA 02138 |
| Product Code | DJG |
| CFR Regulation Number | 862.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-15 |
| Decision Date | 2000-12-11 |