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FDA 510(k)

MYCOPLASMA IGG ELISA TEST SYSTEM

K-Number: K970150 · 1997-06-16

ApplicantZeus Scientific, Inc.
Decision Date1997-06-16
Product CodeLJZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MYCOPLASMA IGG ELISA TEST SYSTEM 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 1997-06-16 under 510(k) number K970150. The device is classified under product code LJZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MYCOPLASMA IGG ELISA TEST SYSTEM?

MYCOPLASMA IGG ELISA TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1997-06-16. The listed applicant is Zeus Scientific, Inc.. The 510(k) number is K970150.

When did MYCOPLASMA IGG ELISA TEST SYSTEM receive FDA 510(k) clearance?

MYCOPLASMA IGG ELISA TEST SYSTEM received FDA 510(k) clearance on 1997-06-16, under 510(k) number K970150.

Who is the listed applicant for MYCOPLASMA IGG ELISA TEST SYSTEM?

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 MYCOPLASMA IGG ELISA TEST SYSTEM?

The FDA product code for MYCOPLASMA IGG ELISA TEST SYSTEM is LJZ.

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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 dIFineK191240ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgM Test SystemK190907ZEUS 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 SystemK113397ZEUS ELISA BORRELIA VLSE-1/PEPC10 IGG/IGM TEST SYSTEMK102425ZEUS ELISA CARDIOLIPIN IGG/IGM/IGA TEST SYSTEM

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Related Devices (Code: LJZ)

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.

K984153THE APTUS (AUTOMATED) APPLICATION OF THE MYCOPLASMA IGM ELISA TEST SYSTEM.Zeus Scientific, Inc.K971503MYCOPLASMA IGM ELISA TEST SYSTEMZeus Scientific, Inc.K971393MYCOPLASMA IGG ELISA TEST SYSTEMImmunoprobe, Inc.K963054IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGM) TEST (3130)GenbioK963055IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGG) TEST 3120GenbioK934550IMMUNOCARD MYCOPLASMAMeridian Diagnostics, Inc.

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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