ONE STEP EDDP (METHADONE METABOLITE) TEST STRIP— 510(k) K092048
Substantially EquivalentBiosite Incorporated
FDA 510(k) clearance K092048 for ONE STEP EDDP (METHADONE METABOLITE) TEST STRIP, Substantially Equivalent on 2010-04-19. Applicant: Biosite Incorporated. Device class: 2.
Clearance details
- Applicant
- Biosite Incorporated
- Product code
- Code DJR
- Device class
- Class 2
- Regulation
- 21 CFR 862.3620
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
Recent devices under product code DJR
view all- K192433 — LZI Methadone II Enzyme Immunoassay
- K182779 — ARK EDDP Assay
- K170416 — LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300) Calibrators
- K160793 — First Sign Drug of Abuse Dip Card Test (MDMA, EDDP, Nortriptyline), First Sign Drug of Abuse Cup Test (MDMA, EDDP, Nortriptyline)
- K152025 — AssureTech Buprenorphine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Methadone Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)
More clearances from Biosite Incorporated
view all- K092987 — INRATIO/INRATIO2 TEST STRIPS
- K093032 — TRIAGE TOTAL 3 CONTROLS AND CALIBRATION VERIFICATION SET
- K080269 — TRIAGE CARDIOPROFILER AND PROFILER S.O.B. PANELS
- K072892 — TRIAGE TOTAL CONTROLS 5, TRIAGE TOTAL CALIBRATION VERIFICATION 5
- K062840 — TRIAGE PROTEIN C CONTROLS AND CALIBRATION VERIFICATION CONTROLS
Data sourced from openFDA. This site is unofficial and independent of the FDA.