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FDA 510(k)

AMEBIASIS ELISA TEST KIT

K-Number: K870318 · 1987-08-11

ApplicantLmd Laboratories
Decision Date1987-08-11
Product CodeKHW
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

AMEBIASIS ELISA TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Lmd Laboratories. It received FDA 510(k) clearance on 1987-08-11 under 510(k) number K870318. 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 ELISA TEST KIT?

AMEBIASIS ELISA TEST KIT is a medical device that received FDA 510(k) clearance on 1987-08-11. The listed applicant is Lmd Laboratories. The 510(k) number is K870318.

When did AMEBIASIS ELISA TEST KIT receive FDA 510(k) clearance?

AMEBIASIS ELISA TEST KIT received FDA 510(k) clearance on 1987-08-11, under 510(k) number K870318.

Who is the listed applicant for AMEBIASIS ELISA TEST KIT?

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

What is the FDA product code for AMEBIASIS ELISA TEST KIT?

The FDA product code for AMEBIASIS ELISA TEST KIT is KHW.

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Other records listing Lmd Laboratories 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.

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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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