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FDA 510(k)

THROMBO-CETIN (RISTOCETIN)

K-Number: K770395 · 1977-03-21

ApplicantBay Area Hema. Onco. Clinic. & Res. L
Decision Date1977-03-21
Product CodeJOZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

THROMBO-CETIN (RISTOCETIN) is the device name listed in this FDA 510(k) record. The listed applicant is Bay Area Hema. Onco. Clinic. & Res. L. It received FDA 510(k) clearance on 1977-03-21 under 510(k) number K770395. 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 THROMBO-CETIN (RISTOCETIN)?

THROMBO-CETIN (RISTOCETIN) is a medical device that received FDA 510(k) clearance on 1977-03-21. The listed applicant is Bay Area Hema. Onco. Clinic. & Res. L. The 510(k) number is K770395.

When did THROMBO-CETIN (RISTOCETIN) receive FDA 510(k) clearance?

THROMBO-CETIN (RISTOCETIN) received FDA 510(k) clearance on 1977-03-21, under 510(k) number K770395.

Who is the listed applicant for THROMBO-CETIN (RISTOCETIN)?

The FDA 510(k) record lists Bay Area Hema. Onco. Clinic. & Res. L as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THROMBO-CETIN (RISTOCETIN)?

The FDA product code for THROMBO-CETIN (RISTOCETIN) 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.

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Other records listing Bay Area Hema. Onco. Clinic. & Res. L 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.

K771678THROMBO-SCREEN PLATELET ADHESIONK770722THROMBO SCREEN QUANTITATIVE HEPARIN ASSAK770394THROMBO-SCREEN AT-111 KIT

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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