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FDA 510(k)

ESA PLASMA FREE METANEPHRINE ANALYSIS KIT

K-Number: K032199 · 2004-01-30

ApplicantEsa, Inc.
Decision Date2004-01-30
Product CodeCHQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ESA PLASMA FREE METANEPHRINE ANALYSIS KIT is the device name listed in this FDA 510(k) record. The listed applicant is Esa, Inc.. It received FDA 510(k) clearance on 2004-01-30 under 510(k) number K032199. 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 ESA PLASMA FREE METANEPHRINE ANALYSIS KIT?

ESA PLASMA FREE METANEPHRINE ANALYSIS KIT is a medical device that received FDA 510(k) clearance on 2004-01-30. The listed applicant is Esa, Inc.. The 510(k) number is K032199.

When did ESA PLASMA FREE METANEPHRINE ANALYSIS KIT receive FDA 510(k) clearance?

ESA PLASMA FREE METANEPHRINE ANALYSIS KIT received FDA 510(k) clearance on 2004-01-30, under 510(k) number K032199.

Who is the listed applicant for ESA PLASMA FREE METANEPHRINE ANALYSIS KIT?

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

What is the FDA product code for ESA PLASMA FREE METANEPHRINE ANALYSIS KIT?

The FDA product code for ESA PLASMA FREE METANEPHRINE ANALYSIS KIT is CHQ.

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Other records listing Esa, 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.

K971640LEADCARE BLOOD LEAD TESTING SYSTEMK963938MODEL 5500 CEASK934977MODEL 5500 CEASK931148MODEL 5500 COULOCHEM ELECTRODE ARRAY SYSTEMK903231COULOCHEM IIK864729NEUROCHEMICAL ANALYZER

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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 GmbHK972167PLASMA CATECHOLAMINE KITBioanalytical Systems, Inc.K963938MODEL 5500 CEASEsa, Inc.K952919URINARY METANEPHRINE KITBioanalytical Systems, Inc.K943099URINARY CATECHOLAMINE KITBioanalytical Systems, Inc.K931148MODEL 5500 COULOCHEM ELECTRODE ARRAY SYSTEMEsa, Inc.

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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