Product code LAS
- Device name
- Drug Specific Control Materials
- Medical specialty
- Clinical Toxicology
- Device class
- 1
- Regulation number
- 862.3280
- Review panel
- TX
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 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 |
| K040411 | DRI OXYCODONE ASSAY | Microgenics Corp. | 2004-05-27 |
| 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 |
| K921939 | SERALYZER(R) THERAPEUTIC DRUG ASSAY CONTROL(ABNOR) | Heraeus Kulzer, Inc. | 1992-07-16 |
| K921141 | CANNABINOID URINE CONTROLS | Diagnostic Reagents, Inc. | 1992-04-17 |
| K915516 | ABUSCREEN ONLINE CANNABINOIDS POSITIVE CONTROL | Roche Diagnostic Systems, Inc. | 1992-01-28 |
| K913677 | ACS THERAPEUTIC DRUG MONIT CONTOLS, LEVEL I,II,III | Analytical Control Systems, Inc. | 1991-09-25 |
| K913336 | ABUSCREEN(R) ONLINE(TM) CONTROLS | Roche Diagnostic Systems, Inc. | 1991-08-26 |
| K913107 | ABUSCREEN(R) ONTRAK(R) POSITIVE REF CONT BENZODIAZ | Roche Diagnostic Systems, Inc. | 1991-08-12 |
| K903061 | UTAK LABORATORIES TOXICOLOGY CONTROL | Utak Laboratories, Inc. | 1991-04-12 |
| K910829 | LYPHOCHEK BENZO/TCA CONTROL SERUM, LEVELS 1 AND 2 | Bio-Rad | 1991-04-03 |
| K910689 | ABUSCREEN(R) ONLINE CONTROLS | Roche Diagnostic Systems, Inc. | 1991-03-11 |
| K894464 | ABUSCREEN POSITIVE REFERENCE CONTROLS | Roche Diagnostic Systems, Inc. | 1989-08-28 |
| K894463 | ABUSCREEN TRI-LEVEL REFERENCE CONTROLS | Roche Diagnostic Systems, Inc. | 1989-08-21 |
| K893857 | ABUSCREEN ONTRAK POS. REF. CONTROL FOR AMPHETAMINE | Roche Diagnostic Systems, Inc. | 1989-08-03 |
| K893858 | ABUSCREEN ONTRAK POS. REFERENCE CONTROL FOR THC | Roche Diagnostic Systems, Inc. | 1989-08-03 |
| K893855 | ABUSCREEN ONTRAK POS. REF. CONTROL FOR BARBITUATES | Roche Diagnostic Systems, Inc. | 1989-08-03 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| B80001696000070 | BUSULFAN LEVEL 1 | UTAK LABORATORIES, INC. | 2022-08-17 |
| B80001696000080 | BUSULFAN LEVEL 2 | UTAK LABORATORIES, INC. | 2022-08-17 |
| B80001696000090 | BUSULFAN LEVEL 3 | UTAK LABORATORIES, INC. | 2022-08-17 |
| B80001978000020 | GHB 20 MG/L | UTAK LABORATORIES, INC. | 2022-08-12 |
| B80000357500020 | DAU +25% GCMS | UTAK LABORATORIES, INC. | 2022-08-11 |
| B80000357500030 | 7-AMINO PLUS 100 NG/ML | UTAK LABORATORIES, INC. | 2022-08-11 |
| B80000357500010 | DAU -25% GCMS | UTAK LABORATORIES, INC. | 2022-08-11 |
| B80001696000020 | METALS LEVEL 2 | UTAK LABORATORIES, INC. | 2022-08-10 |
| B80001696000030 | METALS LEVEL 1 | UTAK LABORATORIES, INC. | 2022-08-10 |
| B80001696000040 | METALS LEVEL 2 | UTAK LABORATORIES, INC. | 2022-08-10 |
| B80001696000010 | METALS LEVEL 1 | UTAK LABORATORIES, INC. | 2022-07-27 |
| B80003716500080 | DRUGS OF ABUSE QC LEVEL 2 | UTAK LABORATORIES, INC. | 2022-06-28 |
| B80003716500070 | DRUGS OF ABUSE QC LEVEL 1 | UTAK LABORATORIES, INC. | 2022-06-28 |
| B80003716500060 | BUPRENORPHINE PLUS LEVEL 2 | UTAK LABORATORIES, INC. | 2022-06-21 |
| B80003716500050 | BUPRENORPHINE PLUS LEVEL 1 | UTAK LABORATORIES, INC. | 2022-06-21 |
| B80002041000020 | DRUGS OF ABUSE LEVEL 2 | UTAK LABORATORIES, INC. | 2022-06-20 |
| B80002041000030 | DRUGS OF ABUSE LEVEL 3 | UTAK LABORATORIES, INC. | 2022-06-20 |
| B80002041000010 | DRUGS OF ABUSE LEVEL 1 | UTAK LABORATORIES, INC. | 2022-06-20 |
| B80003716500040 | FENTANYL PLUS LEVEL 2 | UTAK LABORATORIES, INC. | 2022-06-16 |
| B80003716500030 | FENTANYL PLUS LEVEL 1 | UTAK LABORATORIES, INC. | 2022-06-16 |
| B80002942500100 | P/Z QC V2 LOW | UTAK LABORATORIES, INC. | 2022-06-10 |
| B80002942500090 | OF QC 3 | UTAK LABORATORIES, INC. | 2022-05-06 |
| B80002942500070 | DRUGS OF ABUSE CALIBRATOR V6 | UTAK LABORATORIES, INC. | 2022-05-04 |
| B80002942500050 | P/Z QC LOW | UTAK LABORATORIES, INC. | 2022-05-02 |
| B80001390500020 | URINE QC HIGH | UTAK LABORATORIES, INC. | 2022-05-02 |
| B80001390500010 | URINE QC LOW | UTAK LABORATORIES, INC. | 2022-05-02 |
| B80002942500040 | P/Z CALIBRATOR V2 | UTAK LABORATORIES, INC. | 2022-04-26 |
| B80002509000030 | IMMUNOSUPPRESSANTS QC 3 | UTAK LABORATORIES, INC. | 2020-06-16 |
| B80002509000020 | IMMUNOSUPPRESSANTS QC 2 | UTAK LABORATORIES, INC. | 2020-06-16 |
| B80002509000010 | IMMUNOSUPPRESSANTS QC 1 | UTAK LABORATORIES, INC. | 2020-06-16 |