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FDA 510(k)

ENTAMOEBA TEST

K-Number: K944791 · 1995-03-09

ApplicantTechlab, Inc.
Decision Date1995-03-09
Product CodeKHW
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ENTAMOEBA TEST is the device name listed in this FDA 510(k) record. The listed applicant is Techlab, Inc.. It received FDA 510(k) clearance on 1995-03-09 under 510(k) number K944791. 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 ENTAMOEBA TEST?

ENTAMOEBA TEST is a medical device that received FDA 510(k) clearance on 1995-03-09. The listed applicant is Techlab, Inc.. The 510(k) number is K944791.

When did ENTAMOEBA TEST receive FDA 510(k) clearance?

ENTAMOEBA TEST received FDA 510(k) clearance on 1995-03-09, under 510(k) number K944791.

Who is the listed applicant for ENTAMOEBA TEST?

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

What is the FDA product code for ENTAMOEBA TEST?

The FDA product code for ENTAMOEBA TEST is KHW.

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Other records listing Techlab, Inc. as applicant

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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.K900604DIRECT FLUORESCENT ANTIBODY REAGENT FOR GIARDIABiovir Laboratories, Inc.K890774GIARDEIA(TM)Antibodies, 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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