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FDA 510(k)

OPUS TM T-UPTAKE TEST SYSTEM

K-Number: K902797 · 1990-07-30

ApplicantPb Diagnostic Systems, Inc.
Decision Date1990-07-30
Product CodeKHQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

OPUS TM T-UPTAKE TEST 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 1990-07-30 under 510(k) number K902797. The device is classified under product code KHQ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPUS TM T-UPTAKE TEST SYSTEM?

OPUS TM T-UPTAKE TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1990-07-30. The listed applicant is Pb Diagnostic Systems, Inc.. The 510(k) number is K902797.

When did OPUS TM T-UPTAKE TEST SYSTEM receive FDA 510(k) clearance?

OPUS TM T-UPTAKE TEST SYSTEM received FDA 510(k) clearance on 1990-07-30, under 510(k) number K902797.

Who is the listed applicant for OPUS TM T-UPTAKE TEST 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 TM T-UPTAKE TEST SYSTEM?

The FDA product code for OPUS TM T-UPTAKE TEST SYSTEM is KHQ.

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Other records listing Pb Diagnostic Systems, Inc. as applicant

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K940507OPUS FT4 TEST SYSTEMK934762OPUS PROCAINAMIDE TEST SYSTEMK933389OPUS CMV-GK934137OPUS(R) SEROLOGY CONTROLS, MODIFICATIONK935229OPUS DIGITOXINK934705OPUS NAPA

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Related Devices (Code: KHQ)

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.

K981375ACE T UPTAKE REAGENT TU CALIBRATORSSchiapparelli Biosystems, Inc.K980088T-UPTAKE MICROPLATE EIAMonobindK970539CHIRON DIAGNOSTICS ACS:180TU PChiron Diagnostics Corp.K964308VITROS IMMUNODIAGNOSTICS PRODUCTS T3 UPTAKE REAGENT PACK (GEM.1025) AND T3 UPTAKE CALIBRATORS (GEM.C025)Johnson & Johnson Clinical Diagnostics, Inc.K961488ELECSYS T-UPTAKE ASSAYBoehringer Mannheim Corp.K954807CEDIA T UPTAKE ASSAYBoehringer Mannheim Corp.

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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