FDA 510(k)

CLINIQA LIQUID QC URINALYSIS CONTROLS, LEVELS 1 AND 2

K-Number: K081908 · 2009-01-16

Decision Date2009-01-16

Product CodeJJW

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

CLINIQA LIQUID QC URINALYSIS 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 2009-01-16 under 510(k) number K081908. The device is classified under product code JJW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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

CLINIQA LIQUID QC URINALYSIS CONTROLS, LEVELS 1 AND 2 is a medical device that received FDA 510(k) clearance on 2009-01-16. The listed applicant is Cliniqa Corporation. The 510(k) number is K081908.

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

CLINIQA LIQUID QC URINALYSIS CONTROLS, LEVELS 1 AND 2 received FDA 510(k) clearance on 2009-01-16, under 510(k) number K081908.

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

The FDA product code for CLINIQA LIQUID QC URINALYSIS CONTROLS, LEVELS 1 AND 2 is JJW.

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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 K082107CLINIQA LIQUID QC URINE CHEMISTRY 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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Related Devices (Code: JJW)

K170091UA-Cellular CompleteStreck K110846RANDOX URINALYSIS CONTROLS, LEVELS 1 AND 2Randox Laboratories Limited K103387MISSION LIQUID URINE CONTROL, MISSION LIQUID DIPTUBE URINE CONTROL, MISSION DRY STRIP URINE CONTROLACON Laboratories, Inc.K072640IRISPEC,CA/CB/CCIris Diagnostics K070848LIQUICHEK URINALYSIS CONTROL (BI-LEVEL), CONTROL LEVEL1, LEVEL 2,MINIPAK, 435,436,437,435XBio-Rad, Diagnostics Grp.K052242ADVIA CHEMISTRY MICROALBUMIN CONTROLSBayer Healthcare, LLC

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.