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FDA 510(k)

ESA BIOSCIENCES INC. VITAMIN D HPLC TEST

K-Number: K072536 · 2008-05-07

ApplicantEsa Biosciences, Inc.
Decision Date2008-05-07
Product CodeMRG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ESA BIOSCIENCES INC. VITAMIN D HPLC TEST is the device name listed in this FDA 510(k) record. The listed applicant is Esa Biosciences, Inc.. It received FDA 510(k) clearance on 2008-05-07 under 510(k) number K072536. The device is classified under product code MRG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ESA BIOSCIENCES INC. VITAMIN D HPLC TEST?

ESA BIOSCIENCES INC. VITAMIN D HPLC TEST is a medical device that received FDA 510(k) clearance on 2008-05-07. The listed applicant is Esa Biosciences, Inc.. The 510(k) number is K072536.

When did ESA BIOSCIENCES INC. VITAMIN D HPLC TEST receive FDA 510(k) clearance?

ESA BIOSCIENCES INC. VITAMIN D HPLC TEST received FDA 510(k) clearance on 2008-05-07, under 510(k) number K072536.

Who is the listed applicant for ESA BIOSCIENCES INC. VITAMIN D HPLC TEST?

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

What is the FDA product code for ESA BIOSCIENCES INC. VITAMIN D HPLC TEST?

The FDA product code for ESA BIOSCIENCES INC. VITAMIN D HPLC TEST is MRG.

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.

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Other records listing Esa Biosciences, 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.

K052549LEADCARE II BLOOD LEAD TESTING SYSTEM

Related Devices (Code: MRG)

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.

K232587MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzerShenzhen New Industries Biomedical Engineering Co., Ltd.K221817ALFIS Vitamin D, ALFIS-3 AnalyzerImmunostics Inc.,K223503Access 25(OH) Vitamin D TotalBeckman Coulter, Inc.K210901Elecsys Vitamin D total IIIRoche DiagnosticsK200509ADVIA Centaur Vitamin D Total (VitD)Siemens Healthcare Diagnostics, Inc.K191499MAGLUMI 2000 25-OH Vitamin DShenzhen New Industries Biomedical Engineering Co., 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.

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