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FDA 510(k)

PACIFIC HEMOSTASIS THROMBOPLASTIN D

K-Number: K994100 · 2000-02-18

ApplicantPacific Hemostasis
Decision Date2000-02-18
Product CodeGJS
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

PACIFIC HEMOSTASIS THROMBOPLASTIN D is the device name listed in this FDA 510(k) record. The listed applicant is Pacific Hemostasis. It received FDA 510(k) clearance on 2000-02-18 under 510(k) number K994100. The device is classified under product code GJS. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PACIFIC HEMOSTASIS THROMBOPLASTIN D?

PACIFIC HEMOSTASIS THROMBOPLASTIN D is a medical device that received FDA 510(k) clearance on 2000-02-18. The listed applicant is Pacific Hemostasis. The 510(k) number is K994100.

When did PACIFIC HEMOSTASIS THROMBOPLASTIN D receive FDA 510(k) clearance?

PACIFIC HEMOSTASIS THROMBOPLASTIN D received FDA 510(k) clearance on 2000-02-18, under 510(k) number K994100.

Who is the listed applicant for PACIFIC HEMOSTASIS THROMBOPLASTIN D?

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 THROMBOPLASTIN D?

The FDA product code for PACIFIC HEMOSTASIS THROMBOPLASTIN D is GJS.

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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 PLASMASK992130PACIFIC HEMOSTASIS THROMBOSCREEN 400CK992278HEPARIN CONTROL PLASMA LEVEL 1K992279HEPARIN CONTROL PLASMA LEVEL 2K991321PACIFIC HEMOSTASIS THROMBOSCREEN 200K990046PACIFIC HEMOSTASIS IMMUNODEPLETED FACTOR VIII DEFICIENT PLASMA

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Related Devices (Code: GJS)

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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