The following data is part of a premarket notification filed by Microgenics Corp. with the FDA for Thermo Scientific Cedia Methamphetamine Oft Assay.
Device ID | K101753 |
510k Number | K101753 |
Device Name: | THERMO SCIENTIFIC CEDIA METHAMPHETAMINE OFT ASSAY |
Classification | Gas Chromatography, Methamphetamine |
Applicant | MICROGENICS CORP. 46360 FREMONT BLVD Fremont, CA 94538 |
Contact | Lisa Charter |
Correspondent | Lisa Charter MICROGENICS CORP. 46360 FREMONT BLVD Fremont, CA 94538 |
Product Code | LAF |
CFR Regulation Number | 862.3610 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-06-22 |
Decision Date | 2011-04-08 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00884883011083 | K101753 | 000 |
00884883011014 | K101753 | 000 |
00884883011007 | K101753 | 000 |
00884883000827 | K101753 | 000 |
00884883000230 | K101753 | 000 |