DIF — Drug Mixture Control Materials Class I
FDA Device Classification
Classification Details
- Product Code
- DIF
- Device Class
- Class I
- Regulation Number
- 862.3280
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Toxicology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K153474 | biochemical diagnostics | Detectabuse Liquid Control Urine, Detectabuse Stat-Skreen Liquid Control Urine, | February 23, 2016 |
| K132688 | biochemical diagnostics | SALIVABUSE LIQUID ORAL FLUID CONTROL, SALIVABUSE LIQUID ORAL FLUID CONTROL, AU/N | December 16, 2013 |
| K132174 | techno-path manufacturing | MULTICHEM WBT | September 20, 2013 |
| K121122 | biochemical diagnostic | DETECTABUSE LIQUID CONTROL, DETECTABUSE STAT-SKREEN LIQUID CONTROL | July 3, 2012 |
| K121143 | bio-rad laboratories | LIQUICHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL TILEVEL (1,2 AND 3) | May 18, 2012 |
| K120504 | bio-rad laboratories | LIQUICHEK URINE TOXICOLOGY CONTROL, S10 & S10 MINIPAK, LIQUICHEK URINE TOXICOLOG | March 27, 2012 |
| K103656 | microgenics corporation | THERMO SCIENTIFIC MAS R DOA TOTAL | March 24, 2011 |
| K093577 | bio-rad laboratories | LIQUICHEK OPIATE CONTROL | March 12, 2010 |
| K080085 | thermo fisher scientific | MAS TOX CONTROL | April 30, 2008 |
| K080183 | roche diagnostics | CONTROL SET DAT I, CONTRL SET DAT II, CONTROL SET DAT III, CONTROL SET AMPHETAMI | March 25, 2008 |
| K072721 | bio-rad, diagnostics grp | LYPHOCHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL , ABBOTT IMMUNOSUPPRESSANT MCC | December 11, 2007 |
| K063398 | bionostics | ESA LEADCARE II LEAD CONTROL | December 5, 2006 |
| K062191 | dade behring | DIMENSION VISTA SYSTEM DRUGS OF ABUSE POSITIVE AND NEGATIVE CONTROLS, MODELS KC5 | August 21, 2006 |
| K060788 | biosite incorporated | TRIAGE TOX DRUG SCREEN CONTROL LEVEL 1 MODEL 94413 AND LEVEL 2 MODEL 94414 | July 10, 2006 |
| K060417 | quantimetrix | MODIFICATION TO QUANTIMETRIX URINE DRUGS OF ABUSE CONTROL | March 21, 2006 |
| K052053 | bio-rad | LIQUICHEK QUALITATIVE URINE TOXICOLOGY CONTROL, NEGATIVE, POSITIVE, MINIPAK | August 9, 2005 |
| K050682 | bio-rad laboratories | LIQUICHEK URINE TOXICOLOGY CONTROL (LEVEL C1) | April 29, 2005 |
| K050037 | biosite incorporated | TRIAGE TOX DRUG SCREEN CONTROLS | March 22, 2005 |
| K042865 | bio-rad | LIQUICHEK URINE TOXICOLOGY CONTROL, (LEVELS S1S AND S2S) | November 24, 2004 |
| K041666 | diagnostic chemicals | DC-ACETA/SAL CONTROLS | August 17, 2004 |