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FDA 510(k)

SMARTPREP CENTRIFUGE SYSTEM

K-Number: K991430 · 1999-05-28

ApplicantHarvest Technologies, LLC
Decision Date1999-05-28
Product CodeJQC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SMARTPREP CENTRIFUGE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Harvest Technologies, LLC. It received FDA 510(k) clearance on 1999-05-28 under 510(k) number K991430. 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 SMARTPREP CENTRIFUGE SYSTEM?

SMARTPREP CENTRIFUGE SYSTEM is a medical device that received FDA 510(k) clearance on 1999-05-28. The listed applicant is Harvest Technologies, LLC. The 510(k) number is K991430.

When did SMARTPREP CENTRIFUGE SYSTEM receive FDA 510(k) clearance?

SMARTPREP CENTRIFUGE SYSTEM received FDA 510(k) clearance on 1999-05-28, under 510(k) number K991430.

Who is the listed applicant for SMARTPREP CENTRIFUGE SYSTEM?

The FDA 510(k) record lists Harvest Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SMARTPREP CENTRIFUGE SYSTEM?

The FDA product code for SMARTPREP CENTRIFUGE SYSTEM is JQC.

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 Harvest Technologies, LLC 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.

K000456HARVEST TECHNOLOGIES DUAL LIQUID APPLICATOR, MODEL SK/S: HARVEST DUAL LIQUID APPLICATOR LK/2K983022SMARTCELL PROCESSING SYSTEM

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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