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FDA 510(k)

I-STAT PT CONTROL LEVIEL 1 I-STAT PT CONTROL LEVEL 2

K-Number: K120900 · 2013-05-31

ApplicantCliniqa Corporation
Decision Date2013-05-31
Product CodeGGN
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

I-STAT PT CONTROL LEVIEL 1 I-STAT PT CONTROL LEVEL 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 2013-05-31 under 510(k) number K120900. The device is classified under product code GGN. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the I-STAT PT CONTROL LEVIEL 1 I-STAT PT CONTROL LEVEL 2?

I-STAT PT CONTROL LEVIEL 1 I-STAT PT CONTROL LEVEL 2 is a medical device that received FDA 510(k) clearance on 2013-05-31. The listed applicant is Cliniqa Corporation. The 510(k) number is K120900.

When did I-STAT PT CONTROL LEVIEL 1 I-STAT PT CONTROL LEVEL 2 receive FDA 510(k) clearance?

I-STAT PT CONTROL LEVIEL 1 I-STAT PT CONTROL LEVEL 2 received FDA 510(k) clearance on 2013-05-31, under 510(k) number K120900.

Who is the listed applicant for I-STAT PT CONTROL LEVIEL 1 I-STAT PT CONTROL LEVEL 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 I-STAT PT CONTROL LEVIEL 1 I-STAT PT CONTROL LEVEL 2?

The FDA product code for I-STAT PT CONTROL LEVIEL 1 I-STAT PT CONTROL LEVEL 2 is GGN.

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K121237BETA HCG CONTROL LEVEL 1 BETA HCG CONTROL LEVEL 2 BETA HCG CONTROL LEVEL 3 BETA HCG CALIBRATION VERIFICATION CONTROLS LEK083554CLINIQA LIQUIDQC IMMUNOASSAY CONTROL LEVEL 1, 2 & 3K081908CLINIQA LIQUID QC URINALYSIS CONTROLS, LEVELS 1 AND 2K082107CLINIQA LIQUID QC URINE CHEMISTRY CONTROLS, LEVELS 1 AND 2K080973CLINIQA LIQUID QC COMPLETE CARDIAC MARKER CONTROL, LEVELS 1,2, AND 3; CARDIAC MARKER CONTROL-LOW, AND LINICAL CARDIACK070741CLINIQA LIQUID QC UNASSAYED AND ASSAYED GENERAL CHEMISTRY CONTROL LEVELS 1, 2, & 3

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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.

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