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)

ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY (RPFA)

K-Number: K011337 · 2001-10-16

ApplicantAccumetrics, Inc.
Decision Date2001-10-16
Product CodeJOZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY (RPFA) is the device name listed in this FDA 510(k) record. The listed applicant is Accumetrics, Inc.. It received FDA 510(k) clearance on 2001-10-16 under 510(k) number K011337. The device is classified under product code JOZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY (RPFA)?

ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY (RPFA) is a medical device that received FDA 510(k) clearance on 2001-10-16. The listed applicant is Accumetrics, Inc.. The 510(k) number is K011337.

When did ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY (RPFA) receive FDA 510(k) clearance?

ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY (RPFA) received FDA 510(k) clearance on 2001-10-16, under 510(k) number K011337.

Who is the listed applicant for ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY (RPFA)?

The FDA 510(k) record lists Accumetrics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY (RPFA)?

The FDA product code for ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY (RPFA) is JOZ.

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 Accumetrics, Inc. 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.

K051231VERIFYNOW-P2Y12 ASSAYK042423VERIFYNOW-ASPIRIN ASSAYK012701ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - ASA (RPFA-ASA)K013596MODIFICATION TO ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - TRAP (RPFA-TRAP)K992531ULTEGRA SYSTEM ANALYZER, ULTEGRA SYSTEM RPFA-TRAP TEST CARTIDGES, ULTEGRA SYSTEM RPFA-TRAP LEVEL ONE QC, ULTEGRA SYSTEM

Related Devices (Code: JOZ)

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.

K191364T-TAS 01 Total Thrombus-formation Analysis System Instrument, PL Chip for T-TAS 01, PL Chip Reservoir Set for T-TAS 01, BAPA tube for T-TAS 01Fujimori Kogyo, Co., Ltd.K181777AggreGuide A-100 ADPAggredyne, Inc.K163274AggreGuide A-100 AA Assay, AggreGuide A-100 InstrumentAggredyne, Inc.K161329Chrono-log Platelet Aggregometer, 4 channel; Chrono-log Platelet Aggregometer, 8 channelChrono-Log Corp.K122162AGGREGUIDEAggredyne, Inc.K103555MULTIPLATE 5.0 AGGREGOMETERVerum Diagnostica GmbH

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.

↑