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FDA 510(k)

CHRONO-LOG WHOLE BLOOD LUMI-AGGREGOMETER, MODEL 700

K-Number: K050265 · 2005-10-14

ApplicantChrono-Log Corp.
Decision Date2005-10-14
Product CodeJOZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CHRONO-LOG WHOLE BLOOD LUMI-AGGREGOMETER, MODEL 700 is the device name listed in this FDA 510(k) record. The listed applicant is Chrono-Log Corp.. It received FDA 510(k) clearance on 2005-10-14 under 510(k) number K050265. 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 CHRONO-LOG WHOLE BLOOD LUMI-AGGREGOMETER, MODEL 700?

CHRONO-LOG WHOLE BLOOD LUMI-AGGREGOMETER, MODEL 700 is a medical device that received FDA 510(k) clearance on 2005-10-14. The listed applicant is Chrono-Log Corp.. The 510(k) number is K050265.

When did CHRONO-LOG WHOLE BLOOD LUMI-AGGREGOMETER, MODEL 700 receive FDA 510(k) clearance?

CHRONO-LOG WHOLE BLOOD LUMI-AGGREGOMETER, MODEL 700 received FDA 510(k) clearance on 2005-10-14, under 510(k) number K050265.

Who is the listed applicant for CHRONO-LOG WHOLE BLOOD LUMI-AGGREGOMETER, MODEL 700?

The FDA 510(k) record lists Chrono-Log Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CHRONO-LOG WHOLE BLOOD LUMI-AGGREGOMETER, MODEL 700?

The FDA product code for CHRONO-LOG WHOLE BLOOD LUMI-AGGREGOMETER, MODEL 700 is JOZ.

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Other records listing Chrono-Log Corp. 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.

K161329Chrono-log Platelet Aggregometer, 4 channel; Chrono-log Platelet Aggregometer, 8 channelK032951CHRONO-LOG WHOLE BLOOD AGGREGOMETER, MODELS 591A AND 592AK962426CHRONO-LOG WHOLE BLOOD AGGREGOMETER (WBA) 591/592K945414RISTOCETIN COFACTOR ASSAY KITK940792AGGRO/LINK VW COFACTOR SOFTWAREK932566AGGRO/LINK CONTROL SOFTWARE

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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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