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FDA 510(k)

OPUS(R) ROZO

K-Number: K911834 · 1991-08-12

ApplicantPb Diagnostic Systems, Inc.
Decision Date1991-08-12
Product CodeLGD
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

OPUS(R) ROZO is the device name listed in this FDA 510(k) record. The listed applicant is Pb Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1991-08-12 under 510(k) number K911834. 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) ROZO?

OPUS(R) ROZO is a medical device that received FDA 510(k) clearance on 1991-08-12. The listed applicant is Pb Diagnostic Systems, Inc.. The 510(k) number is K911834.

When did OPUS(R) ROZO receive FDA 510(k) clearance?

OPUS(R) ROZO received FDA 510(k) clearance on 1991-08-12, under 510(k) number K911834.

Who is the listed applicant for OPUS(R) ROZO?

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

What is the FDA product code for OPUS(R) ROZO?

The FDA product code for OPUS(R) ROZO is LGD.

Other records listing Pb Diagnostic Systems, 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.

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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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