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FDA 510(k)

LIQUID THROMBOPLASTIN REAGENT

K-Number: K830331 · 1983-04-05

ApplicantHelena Laboratories
Decision Date1983-04-05
Product CodeGJS
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

LIQUID THROMBOPLASTIN REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 1983-04-05 under 510(k) number K830331. 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 LIQUID THROMBOPLASTIN REAGENT?

LIQUID THROMBOPLASTIN REAGENT is a medical device that received FDA 510(k) clearance on 1983-04-05. The listed applicant is Helena Laboratories. The 510(k) number is K830331.

When did LIQUID THROMBOPLASTIN REAGENT receive FDA 510(k) clearance?

LIQUID THROMBOPLASTIN REAGENT received FDA 510(k) clearance on 1983-04-05, under 510(k) number K830331.

Who is the listed applicant for LIQUID THROMBOPLASTIN REAGENT?

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 LIQUID THROMBOPLASTIN REAGENT?

The FDA product code for LIQUID THROMBOPLASTIN REAGENT is GJS.

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Other records listing Helena Laboratories as applicant

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Related Devices (Code: 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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