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FDA 510(k)

OPUS SEROLOGY CONTROLS

K-Number: K925703 · 1993-04-08

ApplicantPb Diagnostics, Inc.
Decision Date1993-04-08
Product CodeMJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

OPUS SEROLOGY CONTROLS 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 1993-04-08 under 510(k) number K925703. The device is classified under product code MJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPUS SEROLOGY CONTROLS?

OPUS SEROLOGY CONTROLS is a medical device that received FDA 510(k) clearance on 1993-04-08. The listed applicant is Pb Diagnostics, Inc.. The 510(k) number is K925703.

When did OPUS SEROLOGY CONTROLS receive FDA 510(k) clearance?

OPUS SEROLOGY CONTROLS received FDA 510(k) clearance on 1993-04-08, under 510(k) number K925703.

Who is the listed applicant for OPUS SEROLOGY CONTROLS?

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 SEROLOGY CONTROLS?

The FDA product code for OPUS SEROLOGY CONTROLS is MJX.

Related Clinical Trials

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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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.

K921523OPUS(R) TOXO-G TEST SYSTEMK915870OPUS RUBELLA TEST SYSTEMK913080OPUS(R) ANTI CMV-M

Related Devices (Code: MJX)

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.

K101434AUDIT MICROCV PROCALCITONIN LINEARITYAalto Scientific, Ltd.K030067VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLSOrtho-Clinical DiagnosticsK974262SYSCOS IDC - G, IDC, BSC, IDC - GScantibodies Laboratory, Inc.K972986ACCURUN 140 RUBELLA IGG POSITIVE CONTROLBoston Biomedica, Inc.K970100TECH SIMPLE SYPHILIS POSITIVE SERUM CONTROL MONITOR ONTRAK SYPHILIS POSITIVE SERUM CONTROLSimplicity Diagnostics, Inc.K934137OPUS(R) SEROLOGY CONTROLS, MODIFICATIONPb Diagnostic Systems, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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