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FDA 510(k)

TITAN GEL CPK REP SYSTEM

K-Number: K873399 · 1987-10-20

ApplicantHelena Laboratories
Decision Date1987-10-20
Product CodeJHX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TITAN GEL CPK REP SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 1987-10-20 under 510(k) number K873399. The device is classified under product code JHX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TITAN GEL CPK REP SYSTEM?

TITAN GEL CPK REP SYSTEM is a medical device that received FDA 510(k) clearance on 1987-10-20. The listed applicant is Helena Laboratories. The 510(k) number is K873399.

When did TITAN GEL CPK REP SYSTEM receive FDA 510(k) clearance?

TITAN GEL CPK REP SYSTEM received FDA 510(k) clearance on 1987-10-20, under 510(k) number K873399.

Who is the listed applicant for TITAN GEL CPK REP SYSTEM?

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 CPK REP SYSTEM?

The FDA product code for TITAN GEL CPK REP SYSTEM is JHX.

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Related Devices (Code: JHX)

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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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