ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST CARD, ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST DEVICE— 510(k) K023946
Substantially EquivalentACON Laboratories, Inc.
FDA 510(k) clearance K023946 for ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST CARD, ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST DEVICE, Substantially Equivalent on 2003-02-05. Applicant: ACON Laboratories, Inc.. Device class: 2.
Clearance details
- Applicant
- ACON Laboratories, 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
- San Diego, CA, 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 ACON Laboratories, Inc.
view all- K261212 — Flowflex Plus RSV + Flu A/B + COVID Rapid Test
- K251697 — Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip
- K251749 — Flowflex Plus RSV + Flu A/B + COVID Home Test
- K250085 — On Call® Sure GK Blood Glucose & Ketone Monitoring System +1 more
- K250377 — Flowflex Plus COVID-19 + Flu A/B Home Test
Data sourced from openFDA. This site is unofficial and independent of the FDA.