The following data is part of a premarket notification filed by Microgenics Corp. with the FDA for Thermo Scientific Dri Amphetamines Assay.
| Device ID | K093114 |
| 510k Number | K093114 |
| Device Name: | THERMO SCIENTIFIC DRI AMPHETAMINES ASSAY |
| Classification | Enzyme Immunoassay, Amphetamine |
| Applicant | MICROGENICS CORP. 46360 FREMONT BLVD Fremont, CA 94538 |
| Contact | Hewuan Takkele |
| Correspondent | Hewuan Takkele MICROGENICS CORP. 46360 FREMONT BLVD Fremont, CA 94538 |
| Product Code | DKZ |
| CFR Regulation Number | 862.3100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-10-01 |
| Decision Date | 2010-05-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00380740172329 | K093114 | 000 |
| 00380740005566 | K093114 | 000 |