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FDA 510(k)

COAGULATION CONTROL LEVEL 2 (ABNORMAL)

K-Number: K984130 · 1998-12-01

ApplicantPacific Hemostasis
Decision Date1998-12-01
Product CodeGGC
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

COAGULATION CONTROL LEVEL 2 (ABNORMAL) is the device name listed in this FDA 510(k) record. The listed applicant is Pacific Hemostasis. It received FDA 510(k) clearance on 1998-12-01 under 510(k) number K984130. The device is classified under product code GGC. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COAGULATION CONTROL LEVEL 2 (ABNORMAL)?

COAGULATION CONTROL LEVEL 2 (ABNORMAL) is a medical device that received FDA 510(k) clearance on 1998-12-01. The listed applicant is Pacific Hemostasis. The 510(k) number is K984130.

When did COAGULATION CONTROL LEVEL 2 (ABNORMAL) receive FDA 510(k) clearance?

COAGULATION CONTROL LEVEL 2 (ABNORMAL) received FDA 510(k) clearance on 1998-12-01, under 510(k) number K984130.

Who is the listed applicant for COAGULATION CONTROL LEVEL 2 (ABNORMAL)?

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 COAGULATION CONTROL LEVEL 2 (ABNORMAL)?

The FDA product code for COAGULATION CONTROL LEVEL 2 (ABNORMAL) is GGC.

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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 DK992130PACIFIC HEMOSTASIS THROMBOSCREEN 400CK992278HEPARIN CONTROL PLASMA LEVEL 1K992279HEPARIN CONTROL PLASMA LEVEL 2K991321PACIFIC HEMOSTASIS THROMBOSCREEN 200

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Related Devices (Code: GGC)

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.

K102552HEMOSIL LA POSITIVE CONTROLInstrumentation Laboratory COK100103SPECIALTY ASSAYED CONTROL-2Helena LaboratoriesK062306PLASMACON N, PLASMACON L-1, PLASMACON L-2R2 Diagnostics, Inc.K061803STA - CONTROL LA 1+2Diagnostica Stago, Inc.K032804CRYOCHECK WEAK LUPUS POSITIVE CONTROLPrecision BiologicK023312CONTROL PLASMA PDade Behring, 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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