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FDA 510(k)

FACTOR VIII RELATED ANTIGEN ROCKET EID

K-Number: K823267 · 1982-12-28

ApplicantHelena Laboratories
Decision Date1982-12-28
Product CodeGGP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

FACTOR VIII RELATED ANTIGEN ROCKET EID is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 1982-12-28 under 510(k) number K823267. 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 FACTOR VIII RELATED ANTIGEN ROCKET EID?

FACTOR VIII RELATED ANTIGEN ROCKET EID is a medical device that received FDA 510(k) clearance on 1982-12-28. The listed applicant is Helena Laboratories. The 510(k) number is K823267.

When did FACTOR VIII RELATED ANTIGEN ROCKET EID receive FDA 510(k) clearance?

FACTOR VIII RELATED ANTIGEN ROCKET EID received FDA 510(k) clearance on 1982-12-28, under 510(k) number K823267.

Who is the listed applicant for FACTOR VIII RELATED ANTIGEN ROCKET EID?

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 FACTOR VIII RELATED ANTIGEN ROCKET EID?

The FDA product code for FACTOR VIII RELATED ANTIGEN ROCKET EID is GGP.

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Related Devices (Code: 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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