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FDA 510(k)

OPUS FERRITIN TEST SYSTEM

K-Number: K915838 · 1992-03-18

ApplicantPb Diagnostic Systems, Inc.
Decision Date1992-03-18
Product CodeDGE
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

OPUS FERRITIN 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 1992-03-18 under 510(k) number K915838. The device is classified under product code DGE. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPUS FERRITIN TEST SYSTEM?

OPUS FERRITIN TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1992-03-18. The listed applicant is Pb Diagnostic Systems, Inc.. The 510(k) number is K915838.

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

OPUS FERRITIN TEST SYSTEM received FDA 510(k) clearance on 1992-03-18, under 510(k) number K915838.

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

The FDA product code for OPUS FERRITIN TEST SYSTEM is DGE.

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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: DGE)

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.

K871972STRATUS IGE FLUOROMETRIC ENZYME IMMUNOASSAYAmerican Dade

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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