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FDA 510(k)

OPUS TOTAL CK

K-Number: K933675 · 1993-09-08

ApplicantPb Diagnostic Systems, Inc.
Decision Date1993-09-08
Product CodeCGS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

OPUS TOTAL CK 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 1993-09-08 under 510(k) number K933675. The device is classified under product code CGS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPUS TOTAL CK?

OPUS TOTAL CK is a medical device that received FDA 510(k) clearance on 1993-09-08. The listed applicant is Pb Diagnostic Systems, Inc.. The 510(k) number is K933675.

When did OPUS TOTAL CK receive FDA 510(k) clearance?

OPUS TOTAL CK received FDA 510(k) clearance on 1993-09-08, under 510(k) number K933675.

Who is the listed applicant for OPUS TOTAL CK?

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 TOTAL CK?

The FDA product code for OPUS TOTAL CK is CGS.

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Other records listing Pb Diagnostic Systems, Inc. as applicant

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Related Devices (Code: CGS)

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.

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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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