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FDA 510(k)

QUANTECH CK-MB ASSAY

K-Number: K984433 · 1999-11-01

ApplicantQuantech , Ltd.
Decision Date1999-11-01
Product CodeMYT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

QUANTECH CK-MB ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Quantech , Ltd.. It received FDA 510(k) clearance on 1999-11-01 under 510(k) number K984433. 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 QUANTECH CK-MB ASSAY?

QUANTECH CK-MB ASSAY is a medical device that received FDA 510(k) clearance on 1999-11-01. The listed applicant is Quantech , Ltd.. The 510(k) number is K984433.

When did QUANTECH CK-MB ASSAY receive FDA 510(k) clearance?

QUANTECH CK-MB ASSAY received FDA 510(k) clearance on 1999-11-01, under 510(k) number K984433.

Who is the listed applicant for QUANTECH CK-MB ASSAY?

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

What is the FDA product code for QUANTECH CK-MB ASSAY?

The FDA product code for QUANTECH CK-MB ASSAY is MYT.

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 Quantech , Ltd. 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.

K012943THE QUANTECH FASTRAQ AUTOMATED ANALYZER, AND THE QUANTECH PREPAQ TOTAL HCG TEST CARTRIDGEK990258QUANTECH TOTAL B-HCG ASSAY

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 CorporationK033155BIOCENTREX CARDIAC PANELBiocentrex

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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