CLINIQA LIQUID QC CARDIAC MARKER CONTROL LEVELS 1, 2 & 3, TRI-LEVEL— 510(k) K030768
Substantially EquivalentCliniqa Corporation
FDA 510(k) clearance K030768 for CLINIQA LIQUID QC CARDIAC MARKER CONTROL LEVELS 1, 2 & 3, TRI-LEVEL, Substantially Equivalent on 2003-03-21. Applicant: Cliniqa Corporation. Device class: 1.
Clearance details
- Applicant
- Cliniqa Corporation
- Product code
- Code JJT
- Device class
- Class 1
- Regulation
- 21 CFR 862.1660
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Fallbrook, CA, US
Recent devices under product code JJT
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- K021498 — LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1, 2, 3, AND TRILEVEL
- K012656 — LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1,2,3, MODELS 646,647,648
More clearances from Cliniqa Corporation
view all- K120900 — I-STAT PT CONTROL LEVIEL 1 I-STAT PT CONTROL LEVEL 2
- K121237 — BETA HCG CONTROL LEVEL 1 BETA HCG CONTROL LEVEL 2 BETA HCG CONTROL LEVEL 3 BETA HCG CALIBRATION VERIFICATION CONTROLS LE
- K083554 — CLINIQA LIQUIDQC IMMUNOASSAY CONTROL LEVEL 1, 2 & 3
- K081908 — CLINIQA LIQUID QC URINALYSIS CONTROLS, LEVELS 1 AND 2
- K082107 — CLINIQA LIQUID QC URINE CHEMISTRY CONTROLS, LEVELS 1 AND 2
Recalls naming K030768
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K030768.
Data sourced from openFDA. This site is unofficial and independent of the FDA.