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FDA 510(k)

QUANTECH MYOGLOBIN ASSAY

K-Number: K981536 · 1998-06-29

ApplicantHellen Professional Services
Decision Date1998-06-29
Product CodeMVE
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

QUANTECH MYOGLOBIN ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Hellen Professional Services. It received FDA 510(k) clearance on 1998-06-29 under 510(k) number K981536. The device is classified under product code MVE. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUANTECH MYOGLOBIN ASSAY?

QUANTECH MYOGLOBIN ASSAY is a medical device that received FDA 510(k) clearance on 1998-06-29. The listed applicant is Hellen Professional Services. The 510(k) number is K981536.

When did QUANTECH MYOGLOBIN ASSAY receive FDA 510(k) clearance?

QUANTECH MYOGLOBIN ASSAY received FDA 510(k) clearance on 1998-06-29, under 510(k) number K981536.

Who is the listed applicant for QUANTECH MYOGLOBIN ASSAY?

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

What is the FDA product code for QUANTECH MYOGLOBIN ASSAY?

The FDA product code for QUANTECH MYOGLOBIN ASSAY is MVE.

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Other records listing Hellen Professional Services 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.

K020226XENOSTRIP-TV TRICHOMONAS DIAGNOSTIC TEST KIT; CATALOG NUMBERS S1383.01, S1383.02 & S1383.03

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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