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FDA 510(k)

TITAN GEL ISO DOT CPK PROCEDURE

K-Number: K842755 · 1984-09-28

ApplicantHelena Laboratories
Decision Date1984-09-28
Product CodeCGS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TITAN GEL ISO DOT CPK PROCEDURE is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 1984-09-28 under 510(k) number K842755. 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 TITAN GEL ISO DOT CPK PROCEDURE?

TITAN GEL ISO DOT CPK PROCEDURE is a medical device that received FDA 510(k) clearance on 1984-09-28. The listed applicant is Helena Laboratories. The 510(k) number is K842755.

When did TITAN GEL ISO DOT CPK PROCEDURE receive FDA 510(k) clearance?

TITAN GEL ISO DOT CPK PROCEDURE received FDA 510(k) clearance on 1984-09-28, under 510(k) number K842755.

Who is the listed applicant for TITAN GEL ISO DOT CPK PROCEDURE?

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

What is the FDA product code for TITAN GEL ISO DOT CPK PROCEDURE?

The FDA product code for TITAN GEL ISO DOT CPK PROCEDURE is CGS.

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Related Devices (Code: CGS)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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