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FDA 510(k)

BIOTROL TOXO ELISA TEST M

K-Number: K873293 · 1988-04-12

ApplicantBiotrol, USA, Inc.
Decision Date1988-04-12
Product CodeLGD
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BIOTROL TOXO ELISA TEST M is the device name listed in this FDA 510(k) record. The listed applicant is Biotrol, USA, Inc.. It received FDA 510(k) clearance on 1988-04-12 under 510(k) number K873293. 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 BIOTROL TOXO ELISA TEST M?

BIOTROL TOXO ELISA TEST M is a medical device that received FDA 510(k) clearance on 1988-04-12. The listed applicant is Biotrol, USA, Inc.. The 510(k) number is K873293.

When did BIOTROL TOXO ELISA TEST M receive FDA 510(k) clearance?

BIOTROL TOXO ELISA TEST M received FDA 510(k) clearance on 1988-04-12, under 510(k) number K873293.

Who is the listed applicant for BIOTROL TOXO ELISA TEST M?

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

What is the FDA product code for BIOTROL TOXO ELISA TEST M?

The FDA product code for BIOTROL TOXO ELISA TEST M is LGD.

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Other records listing Biotrol, USA, Inc. as applicant

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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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