STC METHADONE INTERCEPT MICRO-PLATE EIA, MODEL 11421— 510(k) K002010
Substantially EquivalentOraSure Technologies, Inc.
FDA 510(k) clearance K002010 for STC METHADONE INTERCEPT MICRO-PLATE EIA, MODEL 11421, Substantially Equivalent on 2000-11-29. Applicant: OraSure Technologies, Inc.. Device class: 2.
Clearance details
- Applicant
- OraSure Technologies, Inc.
- 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
- Bethlehem, PA, 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 OraSure Technologies, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.