510(k) K040411
- Device
- DRI OXYCODONE ASSAY
- Applicant
- MICROGENICS CORP.
- 510(k) number
- K040411
- Product code
- LAS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2004-05-27
- Date received
- 2004-02-18
- Regulation
- 862.3280
- Classification name
- Drug Specific Control Materials
- Medical specialty
- Toxicology
- Review panel
- Toxicology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- DAVID CASAL
- Address
- 46360 Fremont Blvd. Fremont Blvd. CA US 94538 94538
FDA Registration Numbers#
- 3010939897
- 9612890
- 2030861
- 2517506
- 3006198300
- 3004493545
- 3017181603
- 2085085
- 3003951180
- 1220972
- 9610126
- 2020952
- 3003795116
- 3005567065
- 2022375
- 3005755244
- 3037000637
- 1827821
- 2431530
- 2050012
- 9610529
- 3003610499
- 2432235
Source Documents#
Other 510(k) Records For Product Code LAS #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K080459 | CHROMESYTEMS TOXICOLOGY CALIBRATORS AND CONTROLS | Chromsystems Instruments & Chemicals GmbH | 2009-11-17 |
| K072257 | MYCOPHENOLIC ACID CONTROL, LEVEL 1, 2, 3, 4, 4-LEVEL | More Diagnostics | 2008-01-30 |
| K062942 | QUANTIMETRIX NICOSURE COTININE URINE CONTROL | Quantimetrix Corp. | 2006-10-30 |
| K051074 | MAS IMMUNOSUPPRESSANT CONTROLS | Microgenics Corp. | 2005-06-06 |
| K032842 | MICROGENICS CYCLOSPORINE CONTROL KIT | Microgenics Corp. | 2003-10-17 |
| K030616 | CEDIA CYCLOSPORINE PLUS HIGH RANGE CONTROLS 4 AND 5 | Microgenics Corp. | 2003-03-31 |
| K992151 | REFERENCE MATERIAL FOR DELTA-9-THC-COOH IN HUMAN URINE | Consolidated Technologies, Inc. | 1999-07-14 |
| K970517 | INNOFLUOR TOPIRAMATE CONTROL SET | Oxis Intl., Inc. | 1997-05-12 |
| K971210 | SYNCHRON SYSTEMS 10 NG/ML & 40 NG/ML THC URINE CONTROLS | Beckman Instruments, Inc. | 1997-04-17 |
| K946119 | ROCHE-TDM ONLEIN(TM) CONTROLS | Roche Diagnostic Systems, Inc. | 1995-02-07 |
| K943048 | MICROGENICS THC CONTROL SETS | Microgenics Corp. | 1994-08-24 |
| K930844 | ROCHE ABUSCREEN ONTRAK POS. REF. CONTROL-METHADONE | Roche Diagnostic Systems, Inc. | 1994-01-27 |
| K934145 | DUPONT ACA URINE METHADONE CONTROL | E.I. Dupont DE Nemours & Co., Inc. | 1993-11-09 |
| K933557 | REFERENCE MATERIAL FOR PHENCYCLIDINE IN HUMAN URINE | Consolidated Technologies, Inc. | 1993-09-10 |
| K932662 | CYCLOSPORINE (WHOLE BLOOD) CONTROL-PEDIATRIC LEVEL | More Diagnostics | 1993-07-26 |
Legacy Summary#
summary
FDA Review#
Decision Summary