MISSION PLUS HB HEMOGLOBIN TESTING SYSTEM— 510(k) K122553
Substantially EquivalentACON Laboratories, Inc.
FDA 510(k) clearance K122553 for MISSION PLUS HB HEMOGLOBIN TESTING SYSTEM, Substantially Equivalent on 2013-08-05. Applicant: ACON Laboratories, Inc.. Device class: 2.
Clearance details
- Applicant
- ACON Laboratories, Inc.
- Product code
- Code GKR
- Device class
- Class 2
- Regulation
- 21 CFR 864.5620
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
Recent devices under product code GKR
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.