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FDA 510(k)

E. HISTOLYTICA II

K-Number: K994101 · 1999-12-21

ApplicantTechlab, Inc.
Decision Date1999-12-21
Product CodeKHW
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

E. HISTOLYTICA II is the device name listed in this FDA 510(k) record. The listed applicant is Techlab, Inc.. It received FDA 510(k) clearance on 1999-12-21 under 510(k) number K994101. 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 II?

E. HISTOLYTICA II is a medical device that received FDA 510(k) clearance on 1999-12-21. The listed applicant is Techlab, Inc.. The 510(k) number is K994101.

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

E. HISTOLYTICA II received FDA 510(k) clearance on 1999-12-21, under 510(k) number K994101.

Who is the listed applicant for E. HISTOLYTICA II?

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 II?

The FDA product code for E. HISTOLYTICA II 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.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.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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