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FDA 510(k)

URINARY METANEPHRINE KIT

K-Number: K952919 · 1995-09-06

ApplicantBioanalytical Systems, Inc.
Decision Date1995-09-06
Product CodeCHQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

URINARY METANEPHRINE 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 1995-09-06 under 510(k) number K952919. 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 METANEPHRINE KIT?

URINARY METANEPHRINE KIT is a medical device that received FDA 510(k) clearance on 1995-09-06. The listed applicant is Bioanalytical Systems, Inc.. The 510(k) number is K952919.

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

URINARY METANEPHRINE KIT received FDA 510(k) clearance on 1995-09-06, under 510(k) number K952919.

Who is the listed applicant for URINARY METANEPHRINE 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 METANEPHRINE KIT?

The FDA product code for URINARY METANEPHRINE 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 KITK943099URINARY CATECHOLAMINE 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.K943099URINARY CATECHOLAMINE 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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