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FDA 510(k)

STAPHAUREX ZL30

K-Number: K851949 · 1985-05-22

ApplicantWellcome Diagnostics
Decision Date1985-05-22
Product CodeGTN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

STAPHAUREX ZL30 is the device name listed in this FDA 510(k) record. The listed applicant is Wellcome Diagnostics. It received FDA 510(k) clearance on 1985-05-22 under 510(k) number K851949. The device is classified under product code GTN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STAPHAUREX ZL30?

STAPHAUREX ZL30 is a medical device that received FDA 510(k) clearance on 1985-05-22. The listed applicant is Wellcome Diagnostics. The 510(k) number is K851949.

When did STAPHAUREX ZL30 receive FDA 510(k) clearance?

STAPHAUREX ZL30 received FDA 510(k) clearance on 1985-05-22, under 510(k) number K851949.

Who is the listed applicant for STAPHAUREX ZL30?

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

What is the FDA product code for STAPHAUREX ZL30?

The FDA product code for STAPHAUREX ZL30 is GTN.

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Other records listing Wellcome Diagnostics as applicant

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Related Devices (Code: GTN)

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.

K855233DIAGNOSTIC REAGENT SET-RPLAOxoid U.S.A., Inc.K855236DIAGNOSTIC REAGENT TST-RPLAOxoid U.S.A., Inc.K791453AGGLUTINOTEST-STAPHYLOLISINVolu Sol Medical Industries

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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