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FDA 510(k)

HILLCREST AMEBIASIS IHA TEST

K-Number: K853448 · 1985-08-28

ApplicantHillcrest Biologicals
Decision Date1985-08-28
Product CodeKHW
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

HILLCREST AMEBIASIS IHA TEST is the device name listed in this FDA 510(k) record. The listed applicant is Hillcrest Biologicals. It received FDA 510(k) clearance on 1985-08-28 under 510(k) number K853448. 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 HILLCREST AMEBIASIS IHA TEST?

HILLCREST AMEBIASIS IHA TEST is a medical device that received FDA 510(k) clearance on 1985-08-28. The listed applicant is Hillcrest Biologicals. The 510(k) number is K853448.

When did HILLCREST AMEBIASIS IHA TEST receive FDA 510(k) clearance?

HILLCREST AMEBIASIS IHA TEST received FDA 510(k) clearance on 1985-08-28, under 510(k) number K853448.

Who is the listed applicant for HILLCREST AMEBIASIS IHA TEST?

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

What is the FDA product code for HILLCREST AMEBIASIS IHA TEST?

The FDA product code for HILLCREST AMEBIASIS IHA TEST is KHW.

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Other records listing Hillcrest Biologicals 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.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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