ACON U120 URINE ANALYZER, MODEL U111-101— 510(k) K070929
Substantially EquivalentACON Laboratories, Inc.
FDA 510(k) clearance K070929 for ACON U120 URINE ANALYZER, MODEL U111-101, Substantially Equivalent on 2007-07-30. Applicant: ACON Laboratories, Inc.. Device class: 1.
Clearance details
- Applicant
- ACON Laboratories, Inc.
- Product code
- Code KQO
- Device class
- Class 1
- Regulation
- 21 CFR 862.2900
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Antonio, TX, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.