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FDA 510(k)

BIOCENTREX CARDIAC PANEL

K-Number: K033155 · 2004-01-12

ApplicantBiocentrex
Decision Date2004-01-12
Product CodeMYT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BIOCENTREX CARDIAC PANEL is the device name listed in this FDA 510(k) record. The listed applicant is Biocentrex. It received FDA 510(k) clearance on 2004-01-12 under 510(k) number K033155. The device is classified under product code MYT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOCENTREX CARDIAC PANEL?

BIOCENTREX CARDIAC PANEL is a medical device that received FDA 510(k) clearance on 2004-01-12. The listed applicant is Biocentrex. The 510(k) number is K033155.

When did BIOCENTREX CARDIAC PANEL receive FDA 510(k) clearance?

BIOCENTREX CARDIAC PANEL received FDA 510(k) clearance on 2004-01-12, under 510(k) number K033155.

Who is the listed applicant for BIOCENTREX CARDIAC PANEL?

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

What is the FDA product code for BIOCENTREX CARDIAC PANEL?

The FDA product code for BIOCENTREX CARDIAC PANEL is MYT.

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Related Devices (Code: MYT)

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.

K051433I-STAT CREATINE KINASE MB (CK-MB)I-Stat CorporationK984433QUANTECH CK-MB ASSAYQuantech , Ltd.

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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