The following data is part of a premarket notification filed by Microgenics Corp. with the FDA for Cedia Dau Amphetamines/ecstasy Assay.
| Device ID | K010496 |
| 510k Number | K010496 |
| Device Name: | CEDIA DAU AMPHETAMINES/ECSTASY ASSAY |
| Classification | Gas Chromatography, Methamphetamine |
| Applicant | MICROGENICS CORP. 46360 FREMONT BLVD. Fremont, CA 94538 |
| Contact | Sherrie Rinne |
| Correspondent | Sherrie Rinne 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 | 2001-02-21 |
| Decision Date | 2001-05-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884883012523 | K010496 | 000 |
| 00884883004085 | K010496 | 000 |
| 00884883001541 | K010496 | 000 |
| 00884883001534 | K010496 | 000 |