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FDA 510(k)

THROMBOPLASTIN DRIED

K-Number: K780203 · 1978-03-27

ApplicantHyland Therapeutic Div., Travenol Laboratories
Decision Date1978-03-27
Product CodeGJS
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

THROMBOPLASTIN DRIED is the device name listed in this FDA 510(k) record. The listed applicant is Hyland Therapeutic Div., Travenol Laboratories. It received FDA 510(k) clearance on 1978-03-27 under 510(k) number K780203. The device is classified under product code GJS. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THROMBOPLASTIN DRIED?

THROMBOPLASTIN DRIED is a medical device that received FDA 510(k) clearance on 1978-03-27. The listed applicant is Hyland Therapeutic Div., Travenol Laboratories. The 510(k) number is K780203.

When did THROMBOPLASTIN DRIED receive FDA 510(k) clearance?

THROMBOPLASTIN DRIED received FDA 510(k) clearance on 1978-03-27, under 510(k) number K780203.

Who is the listed applicant for THROMBOPLASTIN DRIED?

The FDA 510(k) record lists Hyland Therapeutic Div., Travenol Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THROMBOPLASTIN DRIED?

The FDA product code for THROMBOPLASTIN DRIED is GJS.

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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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