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FDA 510(k)

HELENA THROMBOPLASTIN-MI REAGENT

K-Number: K940310 · 1994-04-20

ApplicantHelena Laboratories
Decision Date1994-04-20
Product CodeGJS
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HELENA THROMBOPLASTIN-MI 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 1994-04-20 under 510(k) number K940310. 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 HELENA THROMBOPLASTIN-MI REAGENT?

HELENA THROMBOPLASTIN-MI REAGENT is a medical device that received FDA 510(k) clearance on 1994-04-20. The listed applicant is Helena Laboratories. The 510(k) number is K940310.

When did HELENA THROMBOPLASTIN-MI REAGENT receive FDA 510(k) clearance?

HELENA THROMBOPLASTIN-MI REAGENT received FDA 510(k) clearance on 1994-04-20, under 510(k) number K940310.

Who is the listed applicant for HELENA THROMBOPLASTIN-MI 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 HELENA THROMBOPLASTIN-MI REAGENT?

The FDA product code for HELENA THROMBOPLASTIN-MI REAGENT is GJS.

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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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