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FDA 510(k)

TOXOELISA TEST KIT

K-Number: K813221 · 1982-01-26

ApplicantM.A. Bioproducts
Decision Date1982-01-26
Product CodeLGD
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

TOXOELISA TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is M.A. Bioproducts. It received FDA 510(k) clearance on 1982-01-26 under 510(k) number K813221. 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 TOXOELISA TEST KIT?

TOXOELISA TEST KIT is a medical device that received FDA 510(k) clearance on 1982-01-26. The listed applicant is M.A. Bioproducts. The 510(k) number is K813221.

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

TOXOELISA TEST KIT received FDA 510(k) clearance on 1982-01-26, under 510(k) number K813221.

Who is the listed applicant for TOXOELISA TEST KIT?

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

What is the FDA product code for TOXOELISA TEST KIT?

The FDA product code for TOXOELISA TEST KIT is LGD.

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Other records listing M.A. Bioproducts 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.

K822883HERPELISA KITK823804MYCOPLASMELISA TEST KITK830045MUMPSELISA TEST KITK830615CYTOMEGELISA STATK823805VARICELISA TEST KITK821967CHLAMYDELISA 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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