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FDA 510(k)

BLOOD PLATELET ASSAY METHOD & APPARATUS

K-Number: K862302 · 1986-07-31

ApplicantBellhouse Medical, Inc.
Decision Date1986-07-31
Product CodeJOZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

BLOOD PLATELET ASSAY METHOD & APPARATUS is the device name listed in this FDA 510(k) record. The listed applicant is Bellhouse Medical, Inc.. It received FDA 510(k) clearance on 1986-07-31 under 510(k) number K862302. 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 BLOOD PLATELET ASSAY METHOD & APPARATUS?

BLOOD PLATELET ASSAY METHOD & APPARATUS is a medical device that received FDA 510(k) clearance on 1986-07-31. The listed applicant is Bellhouse Medical, Inc.. The 510(k) number is K862302.

When did BLOOD PLATELET ASSAY METHOD & APPARATUS receive FDA 510(k) clearance?

BLOOD PLATELET ASSAY METHOD & APPARATUS received FDA 510(k) clearance on 1986-07-31, under 510(k) number K862302.

Who is the listed applicant for BLOOD PLATELET ASSAY METHOD & APPARATUS?

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

What is the FDA product code for BLOOD PLATELET ASSAY METHOD & APPARATUS?

The FDA product code for BLOOD PLATELET ASSAY METHOD & APPARATUS is JOZ.

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Other records listing Bellhouse Medical, 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.

K905022AQUA-GARD WATERPROOF WOUND PATCHK901228MULTI-STRIP

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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