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FDA 510(k)

ACTIN FSL ACTIVATED PTT REAGENT

K-Number: K863594 · 1986-10-17

ApplicantAmerican Dade
Decision Date1986-10-17
Product CodeGGW
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ACTIN FSL 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 1986-10-17 under 510(k) number K863594. 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 FSL ACTIVATED PTT REAGENT?

ACTIN FSL ACTIVATED PTT REAGENT is a medical device that received FDA 510(k) clearance on 1986-10-17. The listed applicant is American Dade. The 510(k) number is K863594.

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

ACTIN FSL ACTIVATED PTT REAGENT received FDA 510(k) clearance on 1986-10-17, under 510(k) number K863594.

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

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

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Related Devices (Code: GGW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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