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FDA 510(k)

OPUS(R) TOXO-G TEST SYSTEM

K-Number: K921523 · 1992-09-14

ApplicantPb Diagnostics, Inc.
Decision Date1992-09-14
Product CodeLGD
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

OPUS(R) TOXO-G TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Pb Diagnostics, Inc.. It received FDA 510(k) clearance on 1992-09-14 under 510(k) number K921523. 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 OPUS(R) TOXO-G TEST SYSTEM?

OPUS(R) TOXO-G TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1992-09-14. The listed applicant is Pb Diagnostics, Inc.. The 510(k) number is K921523.

When did OPUS(R) TOXO-G TEST SYSTEM receive FDA 510(k) clearance?

OPUS(R) TOXO-G TEST SYSTEM received FDA 510(k) clearance on 1992-09-14, under 510(k) number K921523.

Who is the listed applicant for OPUS(R) TOXO-G TEST SYSTEM?

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

What is the FDA product code for OPUS(R) TOXO-G TEST SYSTEM?

The FDA product code for OPUS(R) TOXO-G TEST SYSTEM is LGD.

Related Clinical Trials

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Other records listing Pb Diagnostics, 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.

K925703OPUS SEROLOGY CONTROLSK915870OPUS RUBELLA TEST SYSTEMK913080OPUS(R) ANTI CMV-M

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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