FDA 510(k)

CLINIQA LIQUID QC URINE CHEMISTRY CONTROLS, LEVELS 1 AND 2

K-Number: K082107 · 2008-09-17

Decision Date2008-09-17

Product CodeJJY

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

CLINIQA LIQUID QC URINE CHEMISTRY CONTROLS, LEVELS 1 AND 2 is the device name listed in this FDA 510(k) record. The listed applicant is Cliniqa Corporation. It received FDA 510(k) clearance on 2008-09-17 under 510(k) number K082107. The device is classified under product code JJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLINIQA LIQUID QC URINE CHEMISTRY CONTROLS, LEVELS 1 AND 2?

CLINIQA LIQUID QC URINE CHEMISTRY CONTROLS, LEVELS 1 AND 2 is a medical device that received FDA 510(k) clearance on 2008-09-17. The listed applicant is Cliniqa Corporation. The 510(k) number is K082107.

When did CLINIQA LIQUID QC URINE CHEMISTRY CONTROLS, LEVELS 1 AND 2 receive FDA 510(k) clearance?

CLINIQA LIQUID QC URINE CHEMISTRY CONTROLS, LEVELS 1 AND 2 received FDA 510(k) clearance on 2008-09-17, under 510(k) number K082107.

Who is the listed applicant for CLINIQA LIQUID QC URINE CHEMISTRY CONTROLS, LEVELS 1 AND 2?

The FDA 510(k) record lists Cliniqa Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CLINIQA LIQUID QC URINE CHEMISTRY CONTROLS, LEVELS 1 AND 2?

The FDA product code for CLINIQA LIQUID QC URINE CHEMISTRY CONTROLS, LEVELS 1 AND 2 is JJY.

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Other records listing Cliniqa Corporation as applicant

K120900I-STAT PT CONTROL LEVIEL 1 I-STAT PT CONTROL LEVEL 2 K121237BETA HCG CONTROL LEVEL 1 BETA HCG CONTROL LEVEL 2 BETA HCG CONTROL LEVEL 3 BETA HCG CALIBRATION VERIFICATION CONTROLS LE K083554CLINIQA LIQUIDQC IMMUNOASSAY CONTROL LEVEL 1, 2 & 3 K081908CLINIQA LIQUID QC URINALYSIS CONTROLS, LEVELS 1 AND 2 K080973CLINIQA LIQUID QC COMPLETE CARDIAC MARKER CONTROL, LEVELS 1,2, AND 3; CARDIAC MARKER CONTROL-LOW, AND LINICAL CARDIAC K070741CLINIQA LIQUID QC UNASSAYED AND ASSAYED GENERAL CHEMISTRY CONTROL LEVELS 1, 2, & 3

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.