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FDA 510(k)

EPOC BGEM, EPOC READER, EPOC HOST, EPOC CARE-FILL CAPILLARY TUBE

K-Number: K093297 · 2010-06-09

ApplicantEpocal, Inc.
Decision Date2010-06-09
Product CodeKHP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

EPOC BGEM, EPOC READER, EPOC HOST, EPOC CARE-FILL CAPILLARY TUBE is the device name listed in this FDA 510(k) record. The listed applicant is Epocal, Inc.. It received FDA 510(k) clearance on 2010-06-09 under 510(k) number K093297. The device is classified under product code KHP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EPOC BGEM, EPOC READER, EPOC HOST, EPOC CARE-FILL CAPILLARY TUBE?

EPOC BGEM, EPOC READER, EPOC HOST, EPOC CARE-FILL CAPILLARY TUBE is a medical device that received FDA 510(k) clearance on 2010-06-09. The listed applicant is Epocal, Inc.. The 510(k) number is K093297.

When did EPOC BGEM, EPOC READER, EPOC HOST, EPOC CARE-FILL CAPILLARY TUBE receive FDA 510(k) clearance?

EPOC BGEM, EPOC READER, EPOC HOST, EPOC CARE-FILL CAPILLARY TUBE received FDA 510(k) clearance on 2010-06-09, under 510(k) number K093297.

Who is the listed applicant for EPOC BGEM, EPOC READER, EPOC HOST, EPOC CARE-FILL CAPILLARY TUBE?

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

What is the FDA product code for EPOC BGEM, EPOC READER, EPOC HOST, EPOC CARE-FILL CAPILLARY TUBE?

The FDA product code for EPOC BGEM, EPOC READER, EPOC HOST, EPOC CARE-FILL CAPILLARY TUBE is KHP.

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 Epocal, 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.

K200107epoc Blood Analysis SystemK171247epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide TestK113726EPOC CHLORIDE TEST AND EPOC CREATININE TESTK092849BLOOD COLLECTION TUBE SAMPLES FOR USE WITH POINT OF CARE BLOOD ANALYZERK090109BLOOD GAS, ELECTROLYTE AND METABOLITE TEST CARDK061597EPOC BLOOD ANALYSIS SYSTEM

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Related Devices (Code: KHP)

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.

K130113PICCOLO LACTATE TEST SYSTEMAbaxis, Inc.K113216RAPIDPOINT 500 BLOOD GAS ANALYERSiemens Healthcare DiagnosticsK112955NOVA STATSTRIP LACTATE HOSPITAL METER SYSTEMNova Biomedical CorporationK112430I-STAT LACTATE TEST/I-SAT CG4+CARTRIDGEAbbott Pont of Care, Inc.K100602NOVA STATSTRIP LACTATE HOSPITAL METER, NOVA STATSTRIP LACTATE TEST STRIPSNova Biomedical Corp.K013938IRMA SL BLOOD ANALYSIS SYSTEM LACTATE CARTRIDGEDiametrics Medical, 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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