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FDA 510(k)

GPS PLATELET SEPARATION KIT WITH ANTICOAGULANT ACD-A

K-Number: K030555 · 2003-04-11

ApplicantBiomet, Inc.
Decision Date2003-04-11
Product CodeJQC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GPS PLATELET SEPARATION KIT WITH ANTICOAGULANT ACD-A is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 2003-04-11 under 510(k) number K030555. 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 GPS PLATELET SEPARATION KIT WITH ANTICOAGULANT ACD-A?

GPS PLATELET SEPARATION KIT WITH ANTICOAGULANT ACD-A is a medical device that received FDA 510(k) clearance on 2003-04-11. The listed applicant is Biomet, Inc.. The 510(k) number is K030555.

When did GPS PLATELET SEPARATION KIT WITH ANTICOAGULANT ACD-A receive FDA 510(k) clearance?

GPS PLATELET SEPARATION KIT WITH ANTICOAGULANT ACD-A received FDA 510(k) clearance on 2003-04-11, under 510(k) number K030555.

Who is the listed applicant for GPS PLATELET SEPARATION KIT WITH ANTICOAGULANT ACD-A?

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

What is the FDA product code for GPS PLATELET SEPARATION KIT WITH ANTICOAGULANT ACD-A?

The FDA product code for GPS PLATELET SEPARATION KIT WITH ANTICOAGULANT ACD-A is JQC.

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Other records listing Biomet, Inc. as applicant

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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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