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FDA 510(k)

QUIK-DOT TOXOPLASMOSIS

K-Number: K890048 · 1989-06-09

ApplicantAmpcor, Inc.
Decision Date1989-06-09
Product CodeLLA
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

QUIK-DOT TOXOPLASMOSIS is the device name listed in this FDA 510(k) record. The listed applicant is Ampcor, Inc.. It received FDA 510(k) clearance on 1989-06-09 under 510(k) number K890048. The device is classified under product code LLA. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUIK-DOT TOXOPLASMOSIS?

QUIK-DOT TOXOPLASMOSIS is a medical device that received FDA 510(k) clearance on 1989-06-09. The listed applicant is Ampcor, Inc.. The 510(k) number is K890048.

When did QUIK-DOT TOXOPLASMOSIS receive FDA 510(k) clearance?

QUIK-DOT TOXOPLASMOSIS received FDA 510(k) clearance on 1989-06-09, under 510(k) number K890048.

Who is the listed applicant for QUIK-DOT TOXOPLASMOSIS?

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

What is the FDA product code for QUIK-DOT TOXOPLASMOSIS?

The FDA product code for QUIK-DOT TOXOPLASMOSIS is LLA.

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Other records listing Ampcor, Inc. 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.

K922297INFECTIOUS MONONUCLEOSIS QIK-DOT IM DRY CARD TESTK922296IMFECTIOUS MONONUCLEOSIS IM LIQUID CARD TESTK910438DIPSTICK SALMONELLAK893873SINGLE AND DUAL BAND DIPSTICK HCG TESTK892119QUIK-DOT C REACTIVE PROTEINK892146C REACTIVE PROTEIN LIQUID

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Related Devices (Code: LLA)

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.

K913467TOXOGENBiokit USA, Inc.K850768TOXOSCAN CARD TEST KITBd Becton Dickinson Vacutainer Systems PreanalyticK831930TOXO-SCREEN DA TESTBd Becton Dickinson Vacutainer Systems Preanalytic

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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