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FDA 510(k)

THROMBOSCREEN

K-Number: K820450 · 1982-03-26

ApplicantPacific Hemostasis
Decision Date1982-03-26
Product CodeGIT
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

THROMBOSCREEN is the device name listed in this FDA 510(k) record. The listed applicant is Pacific Hemostasis. It received FDA 510(k) clearance on 1982-03-26 under 510(k) number K820450. The device is classified under product code GIT. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THROMBOSCREEN?

THROMBOSCREEN is a medical device that received FDA 510(k) clearance on 1982-03-26. The listed applicant is Pacific Hemostasis. The 510(k) number is K820450.

When did THROMBOSCREEN receive FDA 510(k) clearance?

THROMBOSCREEN received FDA 510(k) clearance on 1982-03-26, under 510(k) number K820450.

Who is the listed applicant for THROMBOSCREEN?

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 THROMBOSCREEN?

The FDA product code for THROMBOSCREEN is GIT.

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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: GIT)

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.

K890051BIOTRACK APTT CONTROLSBiotrack, Inc.K881999PLATELIN(R) EXCEL LOrganon Teknika Corp.K880711CLP 0.02 M CALCIUM CHLORIDE SOLUTION.Creative Laboratory Products, 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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