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FDA 510(k)

AMEBIASIS BIO-ENZABEAD SCREEN KIT

K-Number: K831133 · 1983-06-08

ApplicantBionetic Laboratory Products
Decision Date1983-06-08
Product CodeKHW
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

AMEBIASIS BIO-ENZABEAD SCREEN KIT 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 1983-06-08 under 510(k) number K831133. The device is classified under product code KHW. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMEBIASIS BIO-ENZABEAD SCREEN KIT?

AMEBIASIS BIO-ENZABEAD SCREEN KIT is a medical device that received FDA 510(k) clearance on 1983-06-08. The listed applicant is Bionetic Laboratory Products. The 510(k) number is K831133.

When did AMEBIASIS BIO-ENZABEAD SCREEN KIT receive FDA 510(k) clearance?

AMEBIASIS BIO-ENZABEAD SCREEN KIT received FDA 510(k) clearance on 1983-06-08, under 510(k) number K831133.

Who is the listed applicant for AMEBIASIS BIO-ENZABEAD SCREEN KIT?

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 AMEBIASIS BIO-ENZABEAD SCREEN KIT?

The FDA product code for AMEBIASIS BIO-ENZABEAD SCREEN KIT is KHW.

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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 ANTIK832069TOXO IPA KIT IAN INDIRECT FLUORESCENTK831760LEGIONELLA IFA KIT IK830820LEGIONELLA DFA KIT IK830227AUTOMATED ELISA READER LBI 300

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Related Devices (Code: KHW)

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.

K170728E. HISTOLYTICA QUIK CHEKTechlab, Inc.K994101E. HISTOLYTICA IITechlab, Inc.K955895E. HISTOLYTICA TESTTechlab, Inc.K954996TREND AMEBIASIS (E.HISTOLYTICA) SEROLOGICAL ELISA TEST SYSTEMTrend Scientific, Inc.K944791ENTAMOEBA TESTTechlab, Inc.K900604DIRECT FLUORESCENT ANTIBODY REAGENT FOR GIARDIABiovir Laboratories, 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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