ACON MOP ONE STEP OPIATE TEST STRIP, ACON MOP STEP OPIATE TEST DEVICE— 510(k) K013380
Substantially EquivalentACON Laboratories, Inc.
FDA 510(k) clearance K013380 for ACON MOP ONE STEP OPIATE TEST STRIP, ACON MOP STEP OPIATE TEST DEVICE, Substantially Equivalent on 2001-12-18. Applicant: ACON Laboratories, Inc.. Device class: 2.
Clearance details
- Applicant
- ACON Laboratories, Inc.
- Product code
- Code DJG
- Device class
- Class 2
- Regulation
- 21 CFR 862.3650
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
Recent devices under product code DJG
view allMore 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.