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FDA 510(k)

COAGULATION CONTROL LEVEL 1 (NORMAL)

K-Number: K984129 · 1998-12-01

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

Device Summary

COAGULATION CONTROL LEVEL 1 (NORMAL) 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 K984129. The device is classified under product code GIZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COAGULATION CONTROL LEVEL 1 (NORMAL)?

COAGULATION CONTROL LEVEL 1 (NORMAL) 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 K984129.

When did COAGULATION CONTROL LEVEL 1 (NORMAL) receive FDA 510(k) clearance?

COAGULATION CONTROL LEVEL 1 (NORMAL) received FDA 510(k) clearance on 1998-12-01, under 510(k) number K984129.

Who is the listed applicant for COAGULATION CONTROL LEVEL 1 (NORMAL)?

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 1 (NORMAL)?

The FDA product code for COAGULATION CONTROL LEVEL 1 (NORMAL) is GIZ.

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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 400CK992279HEPARIN CONTROL PLASMA LEVEL 2K992278HEPARIN CONTROL PLASMA LEVEL 1K991321PACIFIC HEMOSTASIS THROMBOSCREEN 200

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Related Devices (Code: GIZ)

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.

K060968STASIS - I, II AND III; SERATHAN - A, B; INTRIN - EA, SI CALCIUM CHLORIDE 0.02M; FIBRINOGEN CONTROL-NORMAL, LOWWortham Laboratories, Inc.K042941DADE BEHRING HEPARIN CALIBRATOR AND CONTROLSDade Behring, Inc.K023309CONTROL PLASMA NDade Behring, Inc.K013708REFERENCE CHECK, CATALOG NUMBER-RCN-10Precision BiologicK003328ACCUCLOT CONTROL I, MODEL A4089Sigma Diagnostics, Inc.K001256CONTROL PLASMA NDade 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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