510(k) K983127
- Device
- OPIATES 2000 LIQUID OPIATES DRUGS OF ABUSE CONTROL LEVELS G2 AND G3
- Applicant
- MEDICAL ANALYSIS SYSTEMS, INC.
- 510(k) number
- K983127
- Product code
- DIF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1998-09-14
- Date received
- 1998-09-08
- Regulation
- 862.3280
- Classification name
- Drug Mixture Control Materials
- Medical specialty
- Toxicology
- Review panel
- Toxicology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- MARY THORSNESS
- Address
- Lincoln Technology Park 542 Flynn Rd. Camarillo CA US 93012 93012
FDA Registration Numbers#
- 1032263
- 3001431095
- 3010939897
- 2030861
- 2432495
- 2517506
- 3004175381
- 3010127294
- 3005333358
- 3006198300
- 3004493545
- 1319808
- 3000308930
- 1649661
- 2060833
- 1616487
- 3002809144
- 2319772
- 1220649
- 3002642396
- 3013982035
- 3008156187
- 3003593973
- 9610126
- 2020952
- 3003795116
- 2022375
- 3012963943
- 1827821
- 2250051
- 1932270
- 2050012
- 9610529
- 1050155
- 3003610499
- 2016706
- 2050010
- 2030633
- 3014607865
- 2432235
- 1319681
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DIF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K153474 | Detectabuse Liquid Control Urine, Detectabuse Stat-Skreen Liquid Control Urine, Detectabuse Liquid Control Urine, AU/NZ, Detectabuse Liquid Control Urine, Immunoassay Series, Detectabuse Liquid Control Urine, GC/MS and Confirm series | Biochemical Diagnostics, Inc. | 2016-02-23 |
| K132688 | SALIVABUSE LIQUID ORAL FLUID CONTROL, SALIVABUSE LIQUID ORAL FLUID CONTROL, AU/NZ | Biochemical Diagnostics, Inc. | 2013-12-16 |
| K132174 | MULTICHEM WBT | Techno-Path Manufacturing , Ltd. | 2013-09-20 |
| K121122 | DETECTABUSE LIQUID CONTROL, DETECTABUSE STAT-SKREEN LIQUID CONTROL | Biochemical Diagnostic, Inc. | 2012-07-03 |
| K121143 | LIQUICHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL TILEVEL (1,2 AND 3) | Bio-Rad Laboratories | 2012-05-18 |
| K120504 | LIQUICHEK URINE TOXICOLOGY CONTROL, S10 & S10 MINIPAK, LIQUICHEK URINE TOXICOLOGY CONTROL, LEVEL S20 & LEVEL S20 MINIPAK | Bio-Rad Laboratories, Inc. | 2012-03-27 |
| K103656 | THERMO SCIENTIFIC MAS R DOA TOTAL | Microgenics Corporation | 2011-03-24 |
| K093577 | LIQUICHEK OPIATE CONTROL | Bio-Rad Laboratories | 2010-03-12 |
| K080085 | MAS TOX CONTROL | Thermo Fisher Scientific | 2008-04-30 |
| K080183 | CONTROL SET DAT I, CONTRL SET DAT II, CONTROL SET DAT III, CONTROL SET AMPHETAMINE 1000 AND CONTROL SET AMPHETAMINE 500 | Roche Diagnostics Corp. | 2008-03-25 |
| K072721 | LYPHOCHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL , ABBOTT IMMUNOSUPPRESSANT MCC | Bio-Rad, Diagnostics Grp. | 2007-12-11 |
| K063398 | ESA LEADCARE II LEAD CONTROL | Bionostics, Inc. | 2006-12-05 |
| K062191 | DIMENSION VISTA SYSTEM DRUGS OF ABUSE POSITIVE AND NEGATIVE CONTROLS, MODELS KC515 AND KC516 | Dade Behring, Inc. | 2006-08-21 |
| K060788 | TRIAGE TOX DRUG SCREEN CONTROL LEVEL 1 MODEL 94413 AND LEVEL 2 MODEL 94414 | Biosite Incorporated | 2006-07-10 |
| K060417 | MODIFICATION TO QUANTIMETRIX URINE DRUGS OF ABUSE CONTROL | Quantimetrix Corp. | 2006-03-21 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases