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FDA 510(k)

THROMBO SCREEN SICKLE CELL ASSAY SET

K-Number: K854079 · 1985-10-31

ApplicantPacific Hemostasis
Decision Date1985-10-31
Product CodeGHM
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

THROMBO SCREEN SICKLE CELL ASSAY SET is the device name listed in this FDA 510(k) record. The listed applicant is Pacific Hemostasis. It received FDA 510(k) clearance on 1985-10-31 under 510(k) number K854079. The device is classified under product code GHM. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THROMBO SCREEN SICKLE CELL ASSAY SET?

THROMBO SCREEN SICKLE CELL ASSAY SET is a medical device that received FDA 510(k) clearance on 1985-10-31. The listed applicant is Pacific Hemostasis. The 510(k) number is K854079.

When did THROMBO SCREEN SICKLE CELL ASSAY SET receive FDA 510(k) clearance?

THROMBO SCREEN SICKLE CELL ASSAY SET received FDA 510(k) clearance on 1985-10-31, under 510(k) number K854079.

Who is the listed applicant for THROMBO SCREEN SICKLE CELL ASSAY SET?

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 THROMBO SCREEN SICKLE CELL ASSAY SET?

The FDA product code for THROMBO SCREEN SICKLE CELL ASSAY SET is GHM.

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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: GHM)

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.

K023656SICKLE-CHEX SOLUBILITY KITStreck Laboratories, Inc.K013316SICKLE-CHEXStreck Laboratories, Inc.K960947SAS SICKLE CELL TESTSa Scientific, Inc.K911981HEMOCARD HEMOGLOBIN SIsolab, Inc.K910430HEMOCARD-ASIsolab, Inc.K872217THROMBOSCREEN JOSHUA HEMOGLOBIN S SCREENING KITPacific Hemostasis

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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