FDA 510(k)

LINICAL CHEMISTRY CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS

K-Number: K033162 · 2003-10-10

Decision Date2003-10-10

Product CodeJJY

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

LINICAL CHEMISTRY CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Cliniqa Corporation. It received FDA 510(k) clearance on 2003-10-10 under 510(k) number K033162. 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 LINICAL CHEMISTRY CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS?

LINICAL CHEMISTRY CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS is a medical device that received FDA 510(k) clearance on 2003-10-10. The listed applicant is Cliniqa Corporation. The 510(k) number is K033162.

When did LINICAL CHEMISTRY CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS receive FDA 510(k) clearance?

LINICAL CHEMISTRY CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS received FDA 510(k) clearance on 2003-10-10, under 510(k) number K033162.

Who is the listed applicant for LINICAL CHEMISTRY CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS?

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 LINICAL CHEMISTRY CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS?

The FDA product code for LINICAL CHEMISTRY CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS is JJY.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 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

View all 36 devices →

Related Devices (Code: JJY)

K162530Multichem IA PlusTechno-Path Manufacturing K163629Audit MicroControls Linearity FD Tumor Markers IIAalto Scientific, Ltd.K163015Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Liquichek Tumor Marker Control- Trilevel MiniPakBio-Rad Laboratories K153712VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification KitRadiometer America, Inc.K132227LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-TRILEVEL, LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-LEVEL I, LIQUICHEK IMMUNOASSAYBio-Rad Laboratories K132156RANDOX CSF CONTROLS LEVELS 2 AND 3Randox Laboratories, Ltd.

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.