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FDA 510(k)

DIAMEDIX IS-TOXOPLASMA IGM CAPTURE TEST SYSTEM

K-Number: K001707 · 2000-07-07

ApplicantDiamedix Corp.
Decision Date2000-07-07
Product CodeLGD
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

DIAMEDIX IS-TOXOPLASMA IGM CAPTURE TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Diamedix Corp.. It received FDA 510(k) clearance on 2000-07-07 under 510(k) number K001707. The device is classified under product code LGD. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIAMEDIX IS-TOXOPLASMA IGM CAPTURE TEST SYSTEM?

DIAMEDIX IS-TOXOPLASMA IGM CAPTURE TEST SYSTEM is a medical device that received FDA 510(k) clearance on 2000-07-07. The listed applicant is Diamedix Corp.. The 510(k) number is K001707.

When did DIAMEDIX IS-TOXOPLASMA IGM CAPTURE TEST SYSTEM receive FDA 510(k) clearance?

DIAMEDIX IS-TOXOPLASMA IGM CAPTURE TEST SYSTEM received FDA 510(k) clearance on 2000-07-07, under 510(k) number K001707.

Who is the listed applicant for DIAMEDIX IS-TOXOPLASMA IGM CAPTURE TEST SYSTEM?

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 DIAMEDIX IS-TOXOPLASMA IGM CAPTURE TEST SYSTEM?

The FDA product code for DIAMEDIX IS-TOXOPLASMA IGM CAPTURE TEST SYSTEM is LGD.

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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

View all 68 devices →

Related Devices (Code: LGD)

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.

K242022Access Toxo IgGBeckman Coulter, Inc.K242095Access Toxo IgM IIBeckman Coulter, Inc.K233932Alinity i Toxo IgMAbbott LaboratoriesK210596ARCHITECT Toxo IgGAbbott LaboratoriesK162678Elecsys Toxo IgM, Elecsys Toxo IgM PreciControlRoche DiagnosticsK132234LIAISON(R) TOXO IGG II, LIAISON(R) CONTROL TOXO IGG IIDiaSorin, 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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