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FDA 510(k)

DIAGNOSTIC KIT, CPK

K-Number: K780311 · 1978-04-05

ApplicantSclavo, Inc.
Decision Date1978-04-05
Product CodeCGS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DIAGNOSTIC KIT, CPK is the device name listed in this FDA 510(k) record. The listed applicant is Sclavo, Inc.. It received FDA 510(k) clearance on 1978-04-05 under 510(k) number K780311. 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 DIAGNOSTIC KIT, CPK?

DIAGNOSTIC KIT, CPK is a medical device that received FDA 510(k) clearance on 1978-04-05. The listed applicant is Sclavo, Inc.. The 510(k) number is K780311.

When did DIAGNOSTIC KIT, CPK receive FDA 510(k) clearance?

DIAGNOSTIC KIT, CPK received FDA 510(k) clearance on 1978-04-05, under 510(k) number K780311.

Who is the listed applicant for DIAGNOSTIC KIT, CPK?

The FDA 510(k) record lists Sclavo, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIAGNOSTIC KIT, CPK?

The FDA product code for DIAGNOSTIC KIT, CPK is CGS.

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Related Devices (Code: CGS)

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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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