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FDA 510(k)

OPUS IMMUNOASSAY SYSTEM

K-Number: K894159 · 1989-08-03

ApplicantPb Diagnostic Systems, Inc.
Decision Date1989-08-03
Product CodeKHO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

OPUS IMMUNOASSAY SYSTEM 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 1989-08-03 under 510(k) number K894159. The device is classified under product code KHO. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPUS IMMUNOASSAY SYSTEM?

OPUS IMMUNOASSAY SYSTEM is a medical device that received FDA 510(k) clearance on 1989-08-03. The listed applicant is Pb Diagnostic Systems, Inc.. The 510(k) number is K894159.

When did OPUS IMMUNOASSAY SYSTEM receive FDA 510(k) clearance?

OPUS IMMUNOASSAY SYSTEM received FDA 510(k) clearance on 1989-08-03, under 510(k) number K894159.

Who is the listed applicant for OPUS IMMUNOASSAY SYSTEM?

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 IMMUNOASSAY SYSTEM?

The FDA product code for OPUS IMMUNOASSAY SYSTEM is KHO.

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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-GK934137OPUS(R) SEROLOGY CONTROLS, MODIFICATIONK935229OPUS DIGITOXINK934705OPUS NAPA

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Related Devices (Code: KHO)

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.

K112161AQT90 FLEX ANALYZER, AQT90 FLEX MYOGLOBIN TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LVLS 1-3, AQT90 FLEX MYO CAL CARTRIDGE..Radiometer Medical ApsK973547TRIAGE STATMETERBiosite IncorporatedK971103AIA NEXIA-AUTOMATED ENZYME IMMUNOASSAY SYSTEMTosoh Medics, Inc.K962919VITROS IMMUNODIAGNOSTIC SYSTEMJohnson & Johnson Clinical Diagnostics, Inc.K952719BIOCIRCUITS IOS (IN-OFFICE SYSTEM)Biocircuits Corp.K950415FLUOROSCAN NEONATALIsolab, 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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