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FDA 510(k)

SMARTPREP2 BMAC SYSTEM, SMARTPREP PLATELET CONCENTRATION SYSTEM

K-Number: K103340 · 2010-12-06

ApplicantHarvest Technologies, Corp.
Decision Date2010-12-06
Product CodeJQC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SMARTPREP2 BMAC SYSTEM, SMARTPREP PLATELET CONCENTRATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Harvest Technologies, Corp.. It received FDA 510(k) clearance on 2010-12-06 under 510(k) number K103340. 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 SMARTPREP2 BMAC SYSTEM, SMARTPREP PLATELET CONCENTRATION SYSTEM?

SMARTPREP2 BMAC SYSTEM, SMARTPREP PLATELET CONCENTRATION SYSTEM is a medical device that received FDA 510(k) clearance on 2010-12-06. The listed applicant is Harvest Technologies, Corp.. The 510(k) number is K103340.

When did SMARTPREP2 BMAC SYSTEM, SMARTPREP PLATELET CONCENTRATION SYSTEM receive FDA 510(k) clearance?

SMARTPREP2 BMAC SYSTEM, SMARTPREP PLATELET CONCENTRATION SYSTEM received FDA 510(k) clearance on 2010-12-06, under 510(k) number K103340.

Who is the listed applicant for SMARTPREP2 BMAC SYSTEM, SMARTPREP PLATELET CONCENTRATION SYSTEM?

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

What is the FDA product code for SMARTPREP2 BMAC SYSTEM, SMARTPREP PLATELET CONCENTRATION SYSTEM?

The FDA product code for SMARTPREP2 BMAC SYSTEM, SMARTPREP PLATELET CONCENTRATION SYSTEM is JQC.

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Other records listing Harvest Technologies, 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.

K121005ADIPREP ADIPOSE TRANSFER SYSTEMK052925SMARTPREP2 CENTRIFUGE SYSTEMK043261HARVEST GRAFT DELIVERY SYRINGEK020252SMARTJET GRAFTING LIQUID APPLICATOR, MODELS SK/S & LK/2K011032SMARTJET BONE GRAFT LIQUID APPLICATOR (SPRAY TIP), MODEL SK/S, SMARTJET BONE GRAFT LIQUID APPLICATOR (DUAL LUMEN CANNULA

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 CorporationK081345AXP 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.K042473COBE ANGEL WHOLE BLOOD SEPARATION SYSTEMCobe Cardiovascular, Inc.

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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