FDA 510(k)

THROMBOSCREEN APTT REAGENT

K-Number: K891337 · 1989-04-21

Decision Date1989-04-21

Product CodeGFO

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

THROMBOSCREEN APTT REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Pacific Hemostasis. It received FDA 510(k) clearance on 1989-04-21 under 510(k) number K891337. The device is classified under product code GFO. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THROMBOSCREEN APTT REAGENT?

THROMBOSCREEN APTT REAGENT is a medical device that received FDA 510(k) clearance on 1989-04-21. The listed applicant is Pacific Hemostasis. The 510(k) number is K891337.

When did THROMBOSCREEN APTT REAGENT receive FDA 510(k) clearance?

THROMBOSCREEN APTT REAGENT received FDA 510(k) clearance on 1989-04-21, under 510(k) number K891337.

Who is the listed applicant for THROMBOSCREEN APTT REAGENT?

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

What is the FDA product code for THROMBOSCREEN APTT REAGENT?

The FDA product code for THROMBOSCREEN APTT REAGENT is GFO.

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Other records listing Pacific Hemostasis as applicant

K000679THROMBOSTRATE CONTROL PLASMAS K994100PACIFIC HEMOSTASIS THROMBOPLASTIN D K992130PACIFIC HEMOSTASIS THROMBOSCREEN 400C K992279HEPARIN CONTROL PLASMA LEVEL 2 K992278HEPARIN CONTROL PLASMA LEVEL 1 K991321PACIFIC HEMOSTASIS THROMBOSCREEN 200

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Related Devices (Code: GFO)

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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.