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FDA 510(k)

PLATELET CENTRIFUGE

K-Number: K822715 · 1982-09-30

ApplicantBiodynamics Corp.
Decision Date1982-09-30
Product CodeJQC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PLATELET CENTRIFUGE is the device name listed in this FDA 510(k) record. The listed applicant is Biodynamics Corp.. It received FDA 510(k) clearance on 1982-09-30 under 510(k) number K822715. The device is classified under product code JQC. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PLATELET CENTRIFUGE?

PLATELET CENTRIFUGE is a medical device that received FDA 510(k) clearance on 1982-09-30. The listed applicant is Biodynamics Corp.. The 510(k) number is K822715.

When did PLATELET CENTRIFUGE receive FDA 510(k) clearance?

PLATELET CENTRIFUGE received FDA 510(k) clearance on 1982-09-30, under 510(k) number K822715.

Who is the listed applicant for PLATELET CENTRIFUGE?

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

What is the FDA product code for PLATELET CENTRIFUGE?

The FDA product code for PLATELET CENTRIFUGE is JQC.

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Other records listing Biodynamics 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.

K051675BIODYNAMICS BIA 500 BIOMPEDANCE BODY COMPOSITION ANALYZERK884033BIODYNAMICS MODEL 200 BODY COMPOSITION ANALYZERK881631BIODYNAMICS AUTOTRANSFUSION RESERVOIRK881968BIODYNAMICS MODEL BI-400 BODY COMPOSITION ANALYZERK874361BIODYNAMICS MODEL BI-300 BODY COMPOSITION ANALYZERK873807AUTOTRANSFUSION APPARATUS

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Related Devices (Code: JQC)

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.

K183205PureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC SupraPhysiologic Concentrating System 60 mL System, PureBMC SupraPhysiologic Concentrating System 120 mL SystemEmcyte CorporationK103340SMARTPREP2 BMAC SYSTEM, SMARTPREP PLATELET CONCENTRATION SYSTEMHarvest Technologies, Corp.K081345AXP PLATFORM MARROW XPRESS SYSTEM MODEL 8-5137, 8-5138, 8-5139, 8-5140 (PRIMARY)Thermogenesis Corp.K071934MARROWSTIM CONCENTRATION KIT AND MARROWSTIM MINI CONCENTRATION KITBiomet Manufacturing CorpK070666GENESISCS COMPONENT CONCENTRATING SYSTEMPerfusion Partners & Assoc., Inc.K052925SMARTPREP2 CENTRIFUGE SYSTEMHarvest Technologies, 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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