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FDA 510(k)

HELENA FACTOR X DEFICIENT SUBSTRATE

K-Number: K792508 · 1979-12-31

ApplicantHelena Laboratories
Decision Date1979-12-31
Product CodeGGP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HELENA FACTOR X DEFICIENT SUBSTRATE is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 1979-12-31 under 510(k) number K792508. The device is classified under product code GGP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HELENA FACTOR X DEFICIENT SUBSTRATE?

HELENA FACTOR X DEFICIENT SUBSTRATE is a medical device that received FDA 510(k) clearance on 1979-12-31. The listed applicant is Helena Laboratories. The 510(k) number is K792508.

When did HELENA FACTOR X DEFICIENT SUBSTRATE receive FDA 510(k) clearance?

HELENA FACTOR X DEFICIENT SUBSTRATE received FDA 510(k) clearance on 1979-12-31, under 510(k) number K792508.

Who is the listed applicant for HELENA FACTOR X DEFICIENT SUBSTRATE?

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 HELENA FACTOR X DEFICIENT SUBSTRATE?

The FDA product code for HELENA FACTOR X DEFICIENT SUBSTRATE is GGP.

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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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