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FDA 510(k)

CAT-3 CATECHOLAMINE ASSAY KIT

K-Number: K855214 · 1986-03-14

ApplicantWhale Scientific, Inc.
Decision Date1986-03-14
Product CodeCHQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CAT-3 CATECHOLAMINE ASSAY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Whale Scientific, Inc.. It received FDA 510(k) clearance on 1986-03-14 under 510(k) number K855214. The device is classified under product code CHQ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CAT-3 CATECHOLAMINE ASSAY KIT?

CAT-3 CATECHOLAMINE ASSAY KIT is a medical device that received FDA 510(k) clearance on 1986-03-14. The listed applicant is Whale Scientific, Inc.. The 510(k) number is K855214.

When did CAT-3 CATECHOLAMINE ASSAY KIT receive FDA 510(k) clearance?

CAT-3 CATECHOLAMINE ASSAY KIT received FDA 510(k) clearance on 1986-03-14, under 510(k) number K855214.

Who is the listed applicant for CAT-3 CATECHOLAMINE ASSAY KIT?

The FDA 510(k) record lists Whale Scientific, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CAT-3 CATECHOLAMINE ASSAY KIT?

The FDA product code for CAT-3 CATECHOLAMINE ASSAY KIT is CHQ.

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_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Whale Scientific, Inc. as applicant

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.

K841506META-3K780455QUANTITATIVE DETERMINATION OF PORPHYRINS

Related Devices (Code: CHQ)

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.

K051969TRICAT RIA (ADRENALIN/NORADRENALIN/DOPAMINE); KATCOMBI RIA (ADRENALIN/NORADRENALIN); NORADRENALIN RIAIbl GmbHK032199ESA PLASMA FREE METANEPHRINE ANALYSIS KITEsa, Inc.K972167PLASMA CATECHOLAMINE KITBioanalytical Systems, Inc.K963938MODEL 5500 CEASEsa, Inc.K952919URINARY METANEPHRINE KITBioanalytical Systems, Inc.K943099URINARY CATECHOLAMINE KITBioanalytical Systems, Inc.

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.

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