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FDA 510(k)

OPUS(R) SEROLOGY CONTROLS, MODIFICATION

K-Number: K934137 · 1994-03-07

ApplicantPb Diagnostic Systems, Inc.
Decision Date1994-03-07
Product CodeMJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

OPUS(R) SEROLOGY CONTROLS, MODIFICATION 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 1994-03-07 under 510(k) number K934137. 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(R) SEROLOGY CONTROLS, MODIFICATION?

OPUS(R) SEROLOGY CONTROLS, MODIFICATION is a medical device that received FDA 510(k) clearance on 1994-03-07. The listed applicant is Pb Diagnostic Systems, Inc.. The 510(k) number is K934137.

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

OPUS(R) SEROLOGY CONTROLS, MODIFICATION received FDA 510(k) clearance on 1994-03-07, under 510(k) number K934137.

Who is the listed applicant for OPUS(R) SEROLOGY CONTROLS, MODIFICATION?

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) SEROLOGY CONTROLS, MODIFICATION?

The FDA product code for OPUS(R) SEROLOGY CONTROLS, MODIFICATION 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 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.

K940507OPUS FT4 TEST SYSTEMK934762OPUS PROCAINAMIDE TEST SYSTEMK933389OPUS CMV-GK935229OPUS DIGITOXINK934705OPUS NAPAK933066OPUS ESTRADIOL

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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.K925703OPUS SEROLOGY CONTROLSPb Diagnostics, 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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