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FDA 510(k)

VERIFYNOW-P2Y12 ASSAY

K-Number: K051231 · 2005-08-05

ApplicantAccumetrics, Inc.
Decision Date2005-08-05
Product CodeJOZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

VERIFYNOW-P2Y12 ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Accumetrics, Inc.. It received FDA 510(k) clearance on 2005-08-05 under 510(k) number K051231. 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 VERIFYNOW-P2Y12 ASSAY?

VERIFYNOW-P2Y12 ASSAY is a medical device that received FDA 510(k) clearance on 2005-08-05. The listed applicant is Accumetrics, Inc.. The 510(k) number is K051231.

When did VERIFYNOW-P2Y12 ASSAY receive FDA 510(k) clearance?

VERIFYNOW-P2Y12 ASSAY received FDA 510(k) clearance on 2005-08-05, under 510(k) number K051231.

Who is the listed applicant for VERIFYNOW-P2Y12 ASSAY?

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 VERIFYNOW-P2Y12 ASSAY?

The FDA product code for VERIFYNOW-P2Y12 ASSAY is JOZ.

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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.

K042423VERIFYNOW-ASPIRIN ASSAYK012701ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - ASA (RPFA-ASA)K013596MODIFICATION TO ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - TRAP (RPFA-TRAP)K011337ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY (RPFA)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.

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