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FDA 510(k)

ACTIN FS ACTIVATED PTT REAGENT

K-Number: K811589 · 1981-07-16

ApplicantAmerican Dade
Decision Date1981-07-16
Product CodeGGW
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ACTIN FS ACTIVATED PTT REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is American Dade. It received FDA 510(k) clearance on 1981-07-16 under 510(k) number K811589. The device is classified under product code GGW. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACTIN FS ACTIVATED PTT REAGENT?

ACTIN FS ACTIVATED PTT REAGENT is a medical device that received FDA 510(k) clearance on 1981-07-16. The listed applicant is American Dade. The 510(k) number is K811589.

When did ACTIN FS ACTIVATED PTT REAGENT receive FDA 510(k) clearance?

ACTIN FS ACTIVATED PTT REAGENT received FDA 510(k) clearance on 1981-07-16, under 510(k) number K811589.

Who is the listed applicant for ACTIN FS ACTIVATED PTT REAGENT?

The FDA 510(k) record lists American Dade as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACTIN FS ACTIVATED PTT REAGENT?

The FDA product code for ACTIN FS ACTIVATED PTT REAGENT is GGW.

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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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