The following data is part of a premarket notification filed by Psychemedics Corp. with the FDA for Psychemedics Methamphetamine Eia.
Device ID | K111927 |
510k Number | K111927 |
Device Name: | PSYCHEMEDICS METHAMPHETAMINE EIA |
Classification | Gas Chromatography, Methamphetamine |
Applicant | PSYCHEMEDICS CORP. 5832 UPLANDER WAY Culver City, CA 90230 |
Contact | Virginia Hill |
Correspondent | Virginia Hill PSYCHEMEDICS CORP. 5832 UPLANDER WAY Culver City, CA 90230 |
Product Code | LAF |
CFR Regulation Number | 862.3610 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-07-06 |
Decision Date | 2012-05-01 |
Summary: | summary |