FDA 510(k)

CLINIQA LIQUIDQC IMMUNOASSAY CONTROL LEVEL 1, 2 & 3

K-Number: K083554 · 2009-04-21

Decision Date2009-04-21

Product CodeJJY

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

CLINIQA LIQUIDQC IMMUNOASSAY CONTROL LEVEL 1, 2 & 3 is the device name listed in this FDA 510(k) record. The listed applicant is Cliniqa Corporation. It received FDA 510(k) clearance on 2009-04-21 under 510(k) number K083554. 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 LIQUIDQC IMMUNOASSAY CONTROL LEVEL 1, 2 & 3?

CLINIQA LIQUIDQC IMMUNOASSAY CONTROL LEVEL 1, 2 & 3 is a medical device that received FDA 510(k) clearance on 2009-04-21. The listed applicant is Cliniqa Corporation. The 510(k) number is K083554.

When did CLINIQA LIQUIDQC IMMUNOASSAY CONTROL LEVEL 1, 2 & 3 receive FDA 510(k) clearance?

CLINIQA LIQUIDQC IMMUNOASSAY CONTROL LEVEL 1, 2 & 3 received FDA 510(k) clearance on 2009-04-21, under 510(k) number K083554.

Who is the listed applicant for CLINIQA LIQUIDQC IMMUNOASSAY CONTROL LEVEL 1, 2 & 3?

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 LIQUIDQC IMMUNOASSAY CONTROL LEVEL 1, 2 & 3?

The FDA product code for CLINIQA LIQUIDQC IMMUNOASSAY CONTROL LEVEL 1, 2 & 3 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 K081908CLINIQA LIQUID QC URINALYSIS CONTROLS, LEVELS 1 AND 2 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: JJY)

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Official Source

View on FDA Database →

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