MISSION U500 URINE ANALYZER— 510(k) K111221
Substantially EquivalentACON Laboratories, Inc.
FDA 510(k) clearance K111221 for MISSION U500 URINE ANALYZER, Substantially Equivalent on 2012-01-18. Applicant: ACON Laboratories, Inc.. Device class: 2.
Clearance details
- Applicant
- ACON Laboratories, Inc.
- Product code
- Code JIO
- Device class
- Class 2
- Regulation
- 21 CFR 864.6550
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
Recent devices under product code JIO
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- K083724 — WIENER LAB. URINE STRIP 10 AND 11
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More clearances from ACON Laboratories, Inc.
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- 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.