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FDA 510(k)

INDIRECT FLUORESCENT ANTIBODY MYCO

K-Number: K840012 · 1984-02-27

Decision Date1984-02-27
Product CodeGRZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

INDIRECT FLUORESCENT ANTIBODY MYCO is the device name listed in this FDA 510(k) record. The listed applicant is Zeus Technologies. It received FDA 510(k) clearance on 1984-02-27 under 510(k) number K840012. The device is classified under product code GRZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INDIRECT FLUORESCENT ANTIBODY MYCO?

INDIRECT FLUORESCENT ANTIBODY MYCO is a medical device that received FDA 510(k) clearance on 1984-02-27. The listed applicant is Zeus Technologies. The 510(k) number is K840012.

When did INDIRECT FLUORESCENT ANTIBODY MYCO receive FDA 510(k) clearance?

INDIRECT FLUORESCENT ANTIBODY MYCO received FDA 510(k) clearance on 1984-02-27, under 510(k) number K840012.

Who is the listed applicant for INDIRECT FLUORESCENT ANTIBODY MYCO?

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

What is the FDA product code for INDIRECT FLUORESCENT ANTIBODY MYCO?

The FDA product code for INDIRECT FLUORESCENT ANTIBODY MYCO is GRZ.

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.

Other records listing Zeus Technologies 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.

Related Devices (Code: GRZ)

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.

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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