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FDA 510(k)

IMMUNOENZYME TEST SYS-DETECT-IGM ANTI

K-Number: K832900 · 1983-11-14

ApplicantBionetic Laboratory Products
Decision Date1983-11-14
Product CodeGLZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

IMMUNOENZYME TEST SYS-DETECT-IGM ANTI is the device name listed in this FDA 510(k) record. The listed applicant is Bionetic Laboratory Products. It received FDA 510(k) clearance on 1983-11-14 under 510(k) number K832900. 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 IMMUNOENZYME TEST SYS-DETECT-IGM ANTI?

IMMUNOENZYME TEST SYS-DETECT-IGM ANTI is a medical device that received FDA 510(k) clearance on 1983-11-14. The listed applicant is Bionetic Laboratory Products. The 510(k) number is K832900.

When did IMMUNOENZYME TEST SYS-DETECT-IGM ANTI receive FDA 510(k) clearance?

IMMUNOENZYME TEST SYS-DETECT-IGM ANTI received FDA 510(k) clearance on 1983-11-14, under 510(k) number K832900.

Who is the listed applicant for IMMUNOENZYME TEST SYS-DETECT-IGM ANTI?

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

What is the FDA product code for IMMUNOENZYME TEST SYS-DETECT-IGM ANTI?

The FDA product code for IMMUNOENZYME TEST SYS-DETECT-IGM ANTI is GLZ.

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Other records listing Bionetic Laboratory Products as applicant

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K833637VZV BIO-ENZABEAD SCREEN KITK832069TOXO IPA KIT IAN INDIRECT FLUORESCENTK831760LEGIONELLA IFA KIT IK830820LEGIONELLA DFA KIT IK831133AMEBIASIS BIO-ENZABEAD SCREEN KITK830227AUTOMATED ELISA READER LBI 300

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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.K830869POLYCHACO INDIRECT IMMUNOFLUORESCENCEParasitic Disease Consultants

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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