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FDA 510(k)

ZEUA MYCOPLASMA

K-Number: K944417 · 1995-08-01

ApplicantZeus Scientific, Inc.
Decision Date1995-08-01
Product CodeGRZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ZEUA MYCOPLASMA is the device name listed in this FDA 510(k) record. The listed applicant is Zeus Scientific, Inc.. It received FDA 510(k) clearance on 1995-08-01 under 510(k) number K944417. 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 ZEUA MYCOPLASMA?

ZEUA MYCOPLASMA is a medical device that received FDA 510(k) clearance on 1995-08-01. The listed applicant is Zeus Scientific, Inc.. The 510(k) number is K944417.

When did ZEUA MYCOPLASMA receive FDA 510(k) clearance?

ZEUA MYCOPLASMA received FDA 510(k) clearance on 1995-08-01, under 510(k) number K944417.

Who is the listed applicant for ZEUA MYCOPLASMA?

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

What is the FDA product code for ZEUA MYCOPLASMA?

The FDA product code for ZEUA MYCOPLASMA is GRZ.

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Other records listing Zeus Scientific, Inc. 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.

K201956Zeus IFA ANA HEp-2 Test System, Zeus dIFineK190907ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG/IgM Test SystemK191398ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG Test SystemK191240ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgM Test SystemK113397ZEUS ELISA BORRELIA VLSE-1/PEPC10 IGG/IGM TEST SYSTEMK102425ZEUS ELISA CARDIOLIPIN IGG/IGM/IGA TEST SYSTEM

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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.

K946373MYCOPLASMA SLURRY AND MYCOPLASMA CROWNTITRE IFA TEST SYSTEMZeus Scientific, Inc.K931557FULLER LABORATORIES MYCOPLASM PNEUMONIA IFA-IGG TESTFuller Laboratories, Inc.K861716FIAX TEST KIT FOR MYCOPLASMA PNEUMONIAE-G ANTIBODYWhittaker Bioproducts, Inc.K840012INDIRECT FLUORESCENT ANTIBODY MYCOZeus Technologies

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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