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FDA 510(k)

PACIFIC HEMOSTASIS THROMBOSCREEN 400C

K-Number: K992130 · 1999-09-03

ApplicantPacific Hemostasis
Decision Date1999-09-03
Product CodeKQG
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

PACIFIC HEMOSTASIS THROMBOSCREEN 400C is the device name listed in this FDA 510(k) record. The listed applicant is Pacific Hemostasis. It received FDA 510(k) clearance on 1999-09-03 under 510(k) number K992130. The device is classified under product code KQG. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PACIFIC HEMOSTASIS THROMBOSCREEN 400C?

PACIFIC HEMOSTASIS THROMBOSCREEN 400C is a medical device that received FDA 510(k) clearance on 1999-09-03. The listed applicant is Pacific Hemostasis. The 510(k) number is K992130.

When did PACIFIC HEMOSTASIS THROMBOSCREEN 400C receive FDA 510(k) clearance?

PACIFIC HEMOSTASIS THROMBOSCREEN 400C received FDA 510(k) clearance on 1999-09-03, under 510(k) number K992130.

Who is the listed applicant for PACIFIC HEMOSTASIS THROMBOSCREEN 400C?

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 PACIFIC HEMOSTASIS THROMBOSCREEN 400C?

The FDA product code for PACIFIC HEMOSTASIS THROMBOSCREEN 400C is KQG.

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Other records listing Pacific Hemostasis as applicant

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.

K000679THROMBOSTRATE CONTROL PLASMASK994100PACIFIC HEMOSTASIS THROMBOPLASTIN DK992279HEPARIN CONTROL PLASMA LEVEL 2K992278HEPARIN CONTROL PLASMA LEVEL 1K991321PACIFIC HEMOSTASIS THROMBOSCREEN 200K990046PACIFIC HEMOSTASIS IMMUNODEPLETED FACTOR VIII DEFICIENT PLASMA

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Related Devices (Code: KQG)

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.

K050821COAGCARE ANTICOAGULATION MANAGEMENT SYSTEMZycareK021976FIBRON-1, FIBRON-4, QUIKCOAG, FIBRONVital Scientific N.V.K991321PACIFIC HEMOSTASIS THROMBOSCREEN 200Pacific HemostasisK983475HEMOCHRON RESPONSEInternational Technidyne Corp.K902614ELVI 828 DIGICLOT MULTISCANLogos Scientific, Inc.K900685CLOT 2 SEMIAUTOMATIC COAGULATION ANALYZERTexas Intl. Laboratories, Inc.

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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