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FDA 510(k)

PLATELET AGGREGATION PROFILER #PAP-4

K-Number: K821005 · 1982-06-01

ApplicantBio/Data Corp.
Decision Date1982-06-01
Product CodeJBX
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

PLATELET AGGREGATION PROFILER #PAP-4 is the device name listed in this FDA 510(k) record. The listed applicant is Bio/Data Corp.. It received FDA 510(k) clearance on 1982-06-01 under 510(k) number K821005. The device is classified under product code JBX. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PLATELET AGGREGATION PROFILER #PAP-4?

PLATELET AGGREGATION PROFILER #PAP-4 is a medical device that received FDA 510(k) clearance on 1982-06-01. The listed applicant is Bio/Data Corp.. The 510(k) number is K821005.

When did PLATELET AGGREGATION PROFILER #PAP-4 receive FDA 510(k) clearance?

PLATELET AGGREGATION PROFILER #PAP-4 received FDA 510(k) clearance on 1982-06-01, under 510(k) number K821005.

Who is the listed applicant for PLATELET AGGREGATION PROFILER #PAP-4?

The FDA 510(k) record lists Bio/Data Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PLATELET AGGREGATION PROFILER #PAP-4?

The FDA product code for PLATELET AGGREGATION PROFILER #PAP-4 is JBX.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Bio/Data 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.

K001891MICROSAMPLE COAGULATION ANALYZER, MODEL MCA 310-CK943153MICROSAMPLE COAGULATION ANALYZERK893650PLATELET AGGREGATION PROFILER MODEL PAP-4CK881150KINETIC FIBRINOGEN ASSAYK873382PLATELET EXTRACT REAGENTK860751VON WILLEBRAND FAC. DEFIC. ABNORMAL CONTROL PLASMA

View all 37 devices →

Related Devices (Code: JBX)

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.

K932566AGGRO/LINK CONTROL SOFTWAREChrono-Log Corp.K912774ARACHIDONIC ACIDHelena LaboratoriesK881829PAT PLATELET AGGREGATION TESTStreck Laboratories, Inc.K862775ASSERACHROM B-TG KITAmerican Bioproducts Co.K851025AGGRO/LINK COMPUTER INTERFACEChrono-Log Corp.K850592PLATELET AGGREGATION REAGENTChrono-Log Corp.

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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