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FDA 510(k)

E. HISTOLYTICA TEST

K-Number: K955895 · 1996-08-30

ApplicantTechlab, Inc.
Decision Date1996-08-30
Product CodeKHW
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

E. HISTOLYTICA 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 1996-08-30 under 510(k) number K955895. 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 E. HISTOLYTICA TEST?

E. HISTOLYTICA TEST is a medical device that received FDA 510(k) clearance on 1996-08-30. The listed applicant is Techlab, Inc.. The 510(k) number is K955895.

When did E. HISTOLYTICA TEST receive FDA 510(k) clearance?

E. HISTOLYTICA TEST received FDA 510(k) clearance on 1996-08-30, under 510(k) number K955895.

Who is the listed applicant for E. HISTOLYTICA 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 E. HISTOLYTICA TEST?

The FDA product code for E. HISTOLYTICA TEST is KHW.

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Other records listing Techlab, Inc. as applicant

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K191442Campylobacter ChekK191456Campylobacter Quik ChekK181400H. PYLORI CHEK™K181379H. PYLORI QUIK CHEKK173217CAMPYLOBACTER QUIK CHEKK173219CAMPYLOBACTER CHEK

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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.K954996TREND AMEBIASIS (E.HISTOLYTICA) SEROLOGICAL ELISA TEST SYSTEMTrend Scientific, Inc.K944791ENTAMOEBA TESTTechlab, 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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