ACON UTI URINARY TRACT INFECTION TEST STRIPS— 510(k) K063295
Substantially EquivalentACON Laboratories, Inc.
FDA 510(k) clearance K063295 for ACON UTI URINARY TRACT INFECTION TEST STRIPS, Substantially Equivalent on 2007-10-12. Applicant: ACON Laboratories, Inc.. Device class: 1.
Clearance details
- Applicant
- ACON Laboratories, Inc.
- Product code
- Code LJX
- Device class
- Class 1
- Regulation
- 21 CFR 864.7675
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.