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FDA 510(k)

OPUS DIGITOXIN

K-Number: K935229 · 1993-12-22

ApplicantPb Diagnostic Systems, Inc.
Decision Date1993-12-22
Product CodeDPG
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

OPUS DIGITOXIN 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 1993-12-22 under 510(k) number K935229. The device is classified under product code DPG. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPUS DIGITOXIN?

OPUS DIGITOXIN is a medical device that received FDA 510(k) clearance on 1993-12-22. The listed applicant is Pb Diagnostic Systems, Inc.. The 510(k) number is K935229.

When did OPUS DIGITOXIN receive FDA 510(k) clearance?

OPUS DIGITOXIN received FDA 510(k) clearance on 1993-12-22, under 510(k) number K935229.

Who is the listed applicant for OPUS DIGITOXIN?

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 DIGITOXIN?

The FDA product code for OPUS DIGITOXIN is DPG.

Related Clinical Trials

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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, MODIFICATIONK934705OPUS NAPAK933675OPUS TOTAL CK

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Related Devices (Code: DPG)

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.

K812129COAT-A-COUNT DIGITOXIN RIA KITDiagnostic Products Corp.K780075RIALYZE DIGOXINMiles 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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