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FDA 510(k)

IMMUNOZYME TOXOPLASMA ANTIBODY

K-Number: K780352 · 1978-06-28

ApplicantMillipore Corp.
Decision Date1978-06-28
Product CodeGLZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

IMMUNOZYME TOXOPLASMA ANTIBODY is the device name listed in this FDA 510(k) record. The listed applicant is Millipore Corp.. It received FDA 510(k) clearance on 1978-06-28 under 510(k) number K780352. The device is classified under product code GLZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMUNOZYME TOXOPLASMA ANTIBODY?

IMMUNOZYME TOXOPLASMA ANTIBODY is a medical device that received FDA 510(k) clearance on 1978-06-28. The listed applicant is Millipore Corp.. The 510(k) number is K780352.

When did IMMUNOZYME TOXOPLASMA ANTIBODY receive FDA 510(k) clearance?

IMMUNOZYME TOXOPLASMA ANTIBODY received FDA 510(k) clearance on 1978-06-28, under 510(k) number K780352.

Who is the listed applicant for IMMUNOZYME TOXOPLASMA ANTIBODY?

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

What is the FDA product code for IMMUNOZYME TOXOPLASMA ANTIBODY?

The FDA product code for IMMUNOZYME TOXOPLASMA ANTIBODY is GLZ.

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Other records listing Millipore Corp. 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.

K023892MILLEX VV, GV, AND HV SYRINGE FILTER UNITSK013988MILLEX GP STERILIZING FILTER UNIT, MODEL SLGP 033 RK963717MILLEX - MP FILTER UNIT (SLMPO25SS/SLMPL25SS)K941326ULTRAFREE-CLK934069MILLEX, DUALEX (PLUS, ULTRA)K924347WATERS(TM) 996 PDA

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Related Devices (Code: GLZ)

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.

K924882TOXOPLASMA IGM IFA TEST SYSTEMZeus Scientific, Inc.K880007TOXO IGM TESTGull Laboratories, Inc.K850591FIAX TOXO-M ANTIBODIES TEST KITIntl. Diagnostic TechnologyK844287ADPIFA TEST FOR ANTIBODIES TO TOXOPLASMA GONDIIApple Diagnostic ProductsK842664ANTI-TOXOPLASMA GONDII KITAmico Lab, Inc.K832900IMMUNOENZYME TEST SYS-DETECT-IGM ANTIBionetic Laboratory Products

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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