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FDA 510(k)

BIO CHECK WHOLE BLOOD/PLASMA/SERMON MODEL #801116

K-Number: K041619 · 2004-12-17

ApplicantBiocheck, Inc.
Decision Date2004-12-17
Product CodeMMI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BIO CHECK WHOLE BLOOD/PLASMA/SERMON MODEL #801116 is the device name listed in this FDA 510(k) record. The listed applicant is Biocheck, Inc.. It received FDA 510(k) clearance on 2004-12-17 under 510(k) number K041619. The device is classified under product code MMI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIO CHECK WHOLE BLOOD/PLASMA/SERMON MODEL #801116?

BIO CHECK WHOLE BLOOD/PLASMA/SERMON MODEL #801116 is a medical device that received FDA 510(k) clearance on 2004-12-17. The listed applicant is Biocheck, Inc.. The 510(k) number is K041619.

When did BIO CHECK WHOLE BLOOD/PLASMA/SERMON MODEL #801116 receive FDA 510(k) clearance?

BIO CHECK WHOLE BLOOD/PLASMA/SERMON MODEL #801116 received FDA 510(k) clearance on 2004-12-17, under 510(k) number K041619.

Who is the listed applicant for BIO CHECK WHOLE BLOOD/PLASMA/SERMON MODEL #801116?

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

What is the FDA product code for BIO CHECK WHOLE BLOOD/PLASMA/SERMON MODEL #801116?

The FDA product code for BIO CHECK WHOLE BLOOD/PLASMA/SERMON MODEL #801116 is MMI.

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Other records listing Biocheck, 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.

K040030BIOCHECK CARDIAC-1 CRP RAPID TEST, MODEL BC-804114K022660BIOCHECK MYOGLOBIN ELISA, MODEL BC-1117K013062BIOCHECK HUMAN CARDIAC TROPONIN-I IMMUNOASSAY TEST KITK003851BIOCHECK HIGH SENSITIVITY C-REACTIVE PROTEIN ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1119K002294BIOCHECK TESTOSTERONE EIA, MODEL BC-1115K001022BIOCHECK, INC. B-2 MICROGLOBIN ENZYME IMMUNOASAY TEST KIT, MODEL BC-1061

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Related Devices (Code: MMI)

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.

K253051i-STAT hs-TnI cartridge with the i-STAT Alinity SystemAbbott Point of Care, Inc.K252393VITROS Immunodiagnostic Products hs Troponin I Reagent PackOrtho-Clinical Diagnostics, Inc.K243483Access hsTnIBeckman Coulter, Inc.K242870Access hsTnIBeckman Coulter, Inc.K240984i-STAT hs-TnI cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K241165Atellica® IM High-Sensitivity Troponin I (TnIH)Siemens Healthcare Diagnostics, 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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