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FDA 510(k)

HELENA FACTOR XI DEFICIENT SUBSTRATE

K-Number: K792476 · 1979-12-31

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

Device Summary

HELENA FACTOR XI 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 K792476. 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 XI DEFICIENT SUBSTRATE?

HELENA FACTOR XI 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 K792476.

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

HELENA FACTOR XI DEFICIENT SUBSTRATE received FDA 510(k) clearance on 1979-12-31, under 510(k) number K792476.

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

The FDA product code for HELENA FACTOR XI 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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