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FDA 510(k)

TITAN GEL-PC GLYCO-HEME(TM) SYSTEM

K-Number: K880698 · 1988-05-06

ApplicantHelena Laboratories
Decision Date1988-05-06
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

TITAN GEL-PC GLYCO-HEME(TM) 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 1988-05-06 under 510(k) number K880698. 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-PC GLYCO-HEME(TM) SYSTEM?

TITAN GEL-PC GLYCO-HEME(TM) SYSTEM is a medical device that received FDA 510(k) clearance on 1988-05-06. The listed applicant is Helena Laboratories. The 510(k) number is K880698.

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

TITAN GEL-PC GLYCO-HEME(TM) SYSTEM received FDA 510(k) clearance on 1988-05-06, under 510(k) number K880698.

Who is the listed applicant for TITAN GEL-PC GLYCO-HEME(TM) 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-PC GLYCO-HEME(TM) SYSTEM?

The FDA product code for TITAN GEL-PC GLYCO-HEME(TM) SYSTEM is LCP.

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Other records listing Helena Laboratories as applicant

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Related Devices (Code: LCP)

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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