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FDA 510(k)

URINARY CATECHOLAMINE KIT

K-Number: K943099 · 1994-10-07

ApplicantBioanalytical Systems, Inc.
Decision Date1994-10-07
Product CodeCHQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

URINARY CATECHOLAMINE KIT is the device name listed in this FDA 510(k) record. The listed applicant is Bioanalytical Systems, Inc.. It received FDA 510(k) clearance on 1994-10-07 under 510(k) number K943099. 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 URINARY CATECHOLAMINE KIT?

URINARY CATECHOLAMINE KIT is a medical device that received FDA 510(k) clearance on 1994-10-07. The listed applicant is Bioanalytical Systems, Inc.. The 510(k) number is K943099.

When did URINARY CATECHOLAMINE KIT receive FDA 510(k) clearance?

URINARY CATECHOLAMINE KIT received FDA 510(k) clearance on 1994-10-07, under 510(k) number K943099.

Who is the listed applicant for URINARY CATECHOLAMINE KIT?

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

What is the FDA product code for URINARY CATECHOLAMINE KIT?

The FDA product code for URINARY CATECHOLAMINE 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 Bioanalytical Systems, 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.

K972167PLASMA CATECHOLAMINE KITK952919URINARY METANEPHRINE KIT

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.K931148MODEL 5500 COULOCHEM ELECTRODE ARRAY SYSTEMEsa, 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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