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FDA 510(k)

OPUS(R) PROLACTIN TEST SYSTEM

K-Number: K913280 · 1991-08-16

ApplicantPb Diagnostic Systems, Inc.
Decision Date1991-08-16
Product CodeCFT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

OPUS(R) PROLACTIN 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 1991-08-16 under 510(k) number K913280. The device is classified under product code CFT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPUS(R) PROLACTIN TEST SYSTEM?

OPUS(R) PROLACTIN TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1991-08-16. The listed applicant is Pb Diagnostic Systems, Inc.. The 510(k) number is K913280.

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

OPUS(R) PROLACTIN TEST SYSTEM received FDA 510(k) clearance on 1991-08-16, under 510(k) number K913280.

Who is the listed applicant for OPUS(R) PROLACTIN 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(R) PROLACTIN TEST SYSTEM?

The FDA product code for OPUS(R) PROLACTIN TEST SYSTEM is CFT.

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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: CFT)

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.

K971921PROLACTIN (PRL) HORMONE MICROPLATE ELISAMonobindK970281VITROS IMMUNODIAGNOSTIC PRODUCTS PROLACTIN REAGENT PACK/CALIBRATORSJohnson & Johnson Clinical Diagnostics, Inc.K970188SEALITE SCIENCES, INC. AQUALITE PROLACTINSealite Sciences, Inc.K964748ELECSYS PROLACTIN ASSAYBoehringer Mannheim Corp.K960561DSL ACTIVE PROLACTIN ELISA MODEL 10-4500Diagnostic Systems Laboratories, Inc.K960060DSL ACTIVE PROLACTIN IRMADiagnostic Systems Laboratories, 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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