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FDA 510(k)

TOXOSTAT M TEST KIT

K-Number: K875113 · 1988-04-12

ApplicantWhittaker Bioproducts, Inc.
Decision Date1988-04-12
Product CodeLGD
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

TOXOSTAT M TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Whittaker Bioproducts, Inc.. It received FDA 510(k) clearance on 1988-04-12 under 510(k) number K875113. 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 TOXOSTAT M TEST KIT?

TOXOSTAT M TEST KIT is a medical device that received FDA 510(k) clearance on 1988-04-12. The listed applicant is Whittaker Bioproducts, Inc.. The 510(k) number is K875113.

When did TOXOSTAT M TEST KIT receive FDA 510(k) clearance?

TOXOSTAT M TEST KIT received FDA 510(k) clearance on 1988-04-12, under 510(k) number K875113.

Who is the listed applicant for TOXOSTAT M TEST KIT?

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

What is the FDA product code for TOXOSTAT M TEST KIT?

The FDA product code for TOXOSTAT M TEST KIT is LGD.

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Other records listing Whittaker Bioproducts, 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.

K911356LEGIONELLA STAT IGG/IGM TEST KITK9132123M IGE SINGLE POINT FAST TESTK904652LYME STAT M TEST KITK904893FIAX LYME M TEST KITK911473EBNA STAT TEST KITK905468PYLORI-G FIAX TEST KIT

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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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