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FDA 510(k)

TITAN GEL GLYCO-HEME SYSTEM

K-Number: K832087 · 1983-08-24

ApplicantHelena Laboratories
Decision Date1983-08-24
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

TITAN GEL GLYCO-HEME 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 1983-08-24 under 510(k) number K832087. The device is classified under product code LCP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TITAN GEL GLYCO-HEME SYSTEM?

TITAN GEL GLYCO-HEME SYSTEM is a medical device that received FDA 510(k) clearance on 1983-08-24. The listed applicant is Helena Laboratories. The 510(k) number is K832087.

When did TITAN GEL GLYCO-HEME SYSTEM receive FDA 510(k) clearance?

TITAN GEL GLYCO-HEME SYSTEM received FDA 510(k) clearance on 1983-08-24, under 510(k) number K832087.

Who is the listed applicant for TITAN GEL GLYCO-HEME 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 GLYCO-HEME SYSTEM?

The FDA product code for TITAN GEL GLYCO-HEME SYSTEM is LCP.

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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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