The following data is part of a premarket notification filed by Psychemedics Corp. with the FDA for Psychemedics Ria Cocaine Assay.
| Device ID | K010868 |
| 510k Number | K010868 |
| Device Name: | PSYCHEMEDICS RIA COCAINE ASSAY |
| Classification | Radioimmunoassay, Cocaine Metabolite |
| Applicant | PSYCHEMEDICS CORP. 5832 UPLANDER WAY Culver City, CA 90230 |
| Contact | Thomas Cairns |
| Correspondent | Thomas Cairns PSYCHEMEDICS CORP. 5832 UPLANDER WAY Culver City, CA 90230 |
| Product Code | KLN |
| CFR Regulation Number | 862.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-03-23 |
| Decision Date | 2001-11-06 |