Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

PACIFIC HEMOSTASIS THROMBOSCREEN 200

K-Number: K991321 · 1999-06-21

ApplicantPacific Hemostasis
Decision Date1999-06-21
Product CodeKQG
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

PACIFIC HEMOSTASIS THROMBOSCREEN 200 is the device name listed in this FDA 510(k) record. The listed applicant is Pacific Hemostasis. It received FDA 510(k) clearance on 1999-06-21 under 510(k) number K991321. The device is classified under product code KQG. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PACIFIC HEMOSTASIS THROMBOSCREEN 200?

PACIFIC HEMOSTASIS THROMBOSCREEN 200 is a medical device that received FDA 510(k) clearance on 1999-06-21. The listed applicant is Pacific Hemostasis. The 510(k) number is K991321.

When did PACIFIC HEMOSTASIS THROMBOSCREEN 200 receive FDA 510(k) clearance?

PACIFIC HEMOSTASIS THROMBOSCREEN 200 received FDA 510(k) clearance on 1999-06-21, under 510(k) number K991321.

Who is the listed applicant for PACIFIC HEMOSTASIS THROMBOSCREEN 200?

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 THROMBOSCREEN 200?

The FDA product code for PACIFIC HEMOSTASIS THROMBOSCREEN 200 is KQG.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 2K990046PACIFIC HEMOSTASIS IMMUNODEPLETED FACTOR VIII DEFICIENT PLASMA

View all 29 devices →

Related Devices (Code: KQG)

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.

K050821COAGCARE ANTICOAGULATION MANAGEMENT SYSTEMZycareK021976FIBRON-1, FIBRON-4, QUIKCOAG, FIBRONVital Scientific N.V.K992130PACIFIC HEMOSTASIS THROMBOSCREEN 400CPacific HemostasisK983475HEMOCHRON RESPONSEInternational Technidyne Corp.K902614ELVI 828 DIGICLOT MULTISCANLogos Scientific, Inc.K900685CLOT 2 SEMIAUTOMATIC COAGULATION ANALYZERTexas Intl. Laboratories, 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.

↑