OLYMPUS URINE CALIBRATOR— 510(k) K033910
Substantially EquivalentCliniqa Corporation
FDA 510(k) clearance K033910 for OLYMPUS URINE CALIBRATOR, Substantially Equivalent on 2004-01-30. Applicant: Cliniqa Corporation. Device class: 2.
Clearance details
- Applicant
- Cliniqa Corporation
- Product code
- Code JIX
- Device class
- Class 2
- Regulation
- 21 CFR 862.1150
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Fallbrook, CA, US
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- K083554 — CLINIQA LIQUIDQC IMMUNOASSAY CONTROL LEVEL 1, 2 & 3
- K081908 — CLINIQA LIQUID QC URINALYSIS CONTROLS, LEVELS 1 AND 2
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Data sourced from openFDA. This site is unofficial and independent of the FDA.