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FDA 510(k)

PDQ AMEBIASIS

K-Number: K862473 · 1986-08-01

ApplicantDiamedix Corp.
Decision Date1986-08-01
Product CodeKHW
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

PDQ AMEBIASIS is the device name listed in this FDA 510(k) record. The listed applicant is Diamedix Corp.. It received FDA 510(k) clearance on 1986-08-01 under 510(k) number K862473. 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 PDQ AMEBIASIS?

PDQ AMEBIASIS is a medical device that received FDA 510(k) clearance on 1986-08-01. The listed applicant is Diamedix Corp.. The 510(k) number is K862473.

When did PDQ AMEBIASIS receive FDA 510(k) clearance?

PDQ AMEBIASIS received FDA 510(k) clearance on 1986-08-01, under 510(k) number K862473.

Who is the listed applicant for PDQ AMEBIASIS?

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

What is the FDA product code for PDQ AMEBIASIS?

The FDA product code for PDQ AMEBIASIS is KHW.

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Other records listing Diamedix Corp. 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.

K093101MAGO 4SK021394DIAMEDIX IS-RHEUMATOID FACTOR TEST SYSTEMK013956DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I SCREENK013628DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I IGG/IGM TEST SYSTEMK012450DIAMEDIX IS-ANTI-CARDIOLIPIN IGA TEST SYSTEMK012449DIAMEDIX IS-ANTI-CARDIOLIPIN IGG/IGM TEST SYSTEM

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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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