URINE BARBITURATES SCREEN FLEX(TM) REAGENT CARTRIDGE— 510(k) K950137
Substantially EquivalentE.I. Dupont DE Nemours & Co., Inc.
FDA 510(k) clearance K950137 for URINE BARBITURATES SCREEN FLEX(TM) REAGENT CARTRIDGE, Substantially Equivalent on 1995-04-13. Applicant: E.I. Dupont DE Nemours & Co., Inc.. Device class: 2.
Clearance details
- Applicant
- E.I. Dupont DE Nemours & Co., Inc.
- Product code
- Code DIS
- Device class
- Class 2
- Regulation
- 21 CFR 862.3150
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Wilmington, DE, US
Recent devices under product code DIS
view all- K161714 — Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators
- K151211 — AssureTech Secobarbital Strip, AssureTech Oxycodone Strip, AssureTech Secobarbital/Oxycodone Panel Dip, AssureTech Secobarbital/Oxycodone Quick Cup, AssureTech Secobarbital/Oxycodone Turn Key-Split Cup
- K150791 — Healgen Secobarbital Test(Strip, Cassette, Cup, Dip Card), Healgen Burprenorphine Test (Strip, Cassette, Cup, Dip Card), Healgen Methadone Test (Strip, Cassette, Cup, Dip Card)
- K143535 — CR3 Keyless Split Sample Cup Secobarbital- Methadone
- K140665 — GenPrime Snap-Top Split Key Cup
More clearances from E.I. Dupont DE Nemours & Co., Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.