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FDA 510(k)

PLATELET AGGREGATING REAGENTS

K-Number: K780047 · 1978-03-02

ApplicantDade, Baxter Travenol Diagnostics, Inc.
Decision Date1978-03-02
Product CodeJOZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

PLATELET AGGREGATING REAGENTS is the device name listed in this FDA 510(k) record. The listed applicant is Dade, Baxter Travenol Diagnostics, Inc.. It received FDA 510(k) clearance on 1978-03-02 under 510(k) number K780047. 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 PLATELET AGGREGATING REAGENTS?

PLATELET AGGREGATING REAGENTS is a medical device that received FDA 510(k) clearance on 1978-03-02. The listed applicant is Dade, Baxter Travenol Diagnostics, Inc.. The 510(k) number is K780047.

When did PLATELET AGGREGATING REAGENTS receive FDA 510(k) clearance?

PLATELET AGGREGATING REAGENTS received FDA 510(k) clearance on 1978-03-02, under 510(k) number K780047.

Who is the listed applicant for PLATELET AGGREGATING REAGENTS?

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

What is the FDA product code for PLATELET AGGREGATING REAGENTS?

The FDA product code for PLATELET AGGREGATING REAGENTS is JOZ.

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Other records listing Dade, Baxter Travenol Diagnostics, 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.

K800296WHOLE BLOOD GAS CONTROL, LEVELS 1,2,&3K792606WHOLE BLOOD PLATELET CONTROL NORMAL,K792723BLOOD FLUID FILTERSK792607T3 UPTAKE (T3U) REAGENTSK792443TSH RADIOIMMUNOASSAYK792442FERRITIN RADIOIMMUNOASSAY

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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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