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FDA 510(k)

OPUS T4 TEST SYSTEM

K-Number: K897193 · 1990-03-19

ApplicantPb Diagnostic Systems, Inc.
Decision Date1990-03-19
Product CodeKLI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

OPUS T4 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 1990-03-19 under 510(k) number K897193. The device is classified under product code KLI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPUS T4 TEST SYSTEM?

OPUS T4 TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1990-03-19. The listed applicant is Pb Diagnostic Systems, Inc.. The 510(k) number is K897193.

When did OPUS T4 TEST SYSTEM receive FDA 510(k) clearance?

OPUS T4 TEST SYSTEM received FDA 510(k) clearance on 1990-03-19, under 510(k) number K897193.

Who is the listed applicant for OPUS T4 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 T4 TEST SYSTEM?

The FDA product code for OPUS T4 TEST SYSTEM is KLI.

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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: KLI)

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.

K160495VITROS® Automation SolutionsOrtho-Clinical Diagnostics, Inc.K131515ACE -GT REAGENT; ACE LIPASE RAGENT; ACE T4 REAGENTAlfa WassermannK103484GSP NEONATAL THYROXINE (T4)Wallac Oy, A Subsidiary of Perkinelmer, Inc.K082638ADVIA CENTAUR SYSTEM WITH STREAMLAB ANALYTICAL WORKCELLSiemens Healthcare Diagnostics, Inc.K030860ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300MonobindK023369ACCESS TOTAL T4 ASSAYBeckman Coulter, 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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