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FDA 510(k)

TOXO IPA KIT IAN INDIRECT FLUORESCENT

K-Number: K832069 · 1983-09-26

ApplicantBionetic Laboratory Products
Decision Date1983-09-26
Product CodeLJK
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

TOXO IPA KIT IAN INDIRECT FLUORESCENT 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 1983-09-26 under 510(k) number K832069. The device is classified under product code LJK. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TOXO IPA KIT IAN INDIRECT FLUORESCENT?

TOXO IPA KIT IAN INDIRECT FLUORESCENT is a medical device that received FDA 510(k) clearance on 1983-09-26. The listed applicant is Bionetic Laboratory Products. The 510(k) number is K832069.

When did TOXO IPA KIT IAN INDIRECT FLUORESCENT receive FDA 510(k) clearance?

TOXO IPA KIT IAN INDIRECT FLUORESCENT received FDA 510(k) clearance on 1983-09-26, under 510(k) number K832069.

Who is the listed applicant for TOXO IPA KIT IAN INDIRECT FLUORESCENT?

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 TOXO IPA KIT IAN INDIRECT FLUORESCENT?

The FDA product code for TOXO IPA KIT IAN INDIRECT FLUORESCENT is LJK.

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Other records listing Bionetic Laboratory Products 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.

K833637VZV BIO-ENZABEAD SCREEN KITK832900IMMUNOENZYME TEST SYS-DETECT-IGM ANTIK831760LEGIONELLA IFA KIT IK830820LEGIONELLA DFA KIT IK831133AMEBIASIS BIO-ENZABEAD SCREEN KITK830227AUTOMATED ELISA READER LBI 300

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Related Devices (Code: LJK)

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.

K974261ACCURUN 135 TOXOPLASMA IGG POSITIVE CONTROLBoston Biomedica, Inc.K911771ARD(TM) ANTIMICROBIAL REMOVAL DEVICEBd Becton Dickinson Vacutainer Systems PreanalyticK861122THE GOLDEN QUAD TEST (TOXO)Microbiological Research Corp.K861460SOLID STATE CONTINUOUS FLOW CONTROL MODEL W/K101Widran Urological Group, Ltd.K822605TOXOPLASMA GONDII ANTIBODY IGGImmulok, 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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