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FDA 510(k)

LEUCOPREP(R) BRAND CELL SEPARAT TUBE W/SODIUM CITR

K-Number: K911731 · 1992-12-15

ApplicantBd Becton Dickinson Vacutainer Systems Preanalytic
Decision Date1992-12-15
Product CodeJCF
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

LEUCOPREP(R) BRAND CELL SEPARAT TUBE W/SODIUM CITR is the device name listed in this FDA 510(k) record. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. It received FDA 510(k) clearance on 1992-12-15 under 510(k) number K911731. The device is classified under product code JCF. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LEUCOPREP(R) BRAND CELL SEPARAT TUBE W/SODIUM CITR?

LEUCOPREP(R) BRAND CELL SEPARAT TUBE W/SODIUM CITR is a medical device that received FDA 510(k) clearance on 1992-12-15. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. The 510(k) number is K911731.

When did LEUCOPREP(R) BRAND CELL SEPARAT TUBE W/SODIUM CITR receive FDA 510(k) clearance?

LEUCOPREP(R) BRAND CELL SEPARAT TUBE W/SODIUM CITR received FDA 510(k) clearance on 1992-12-15, under 510(k) number K911731.

Who is the listed applicant for LEUCOPREP(R) BRAND CELL SEPARAT TUBE W/SODIUM CITR?

The FDA 510(k) record lists Bd Becton Dickinson Vacutainer Systems Preanalytic as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LEUCOPREP(R) BRAND CELL SEPARAT TUBE W/SODIUM CITR?

The FDA product code for LEUCOPREP(R) BRAND CELL SEPARAT TUBE W/SODIUM CITR is JCF.

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Related Devices (Code: JCF)

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.

K902445LYMPHO SEP(TM)Icn Biomedicals, Inc.K891407LEUCOPREP CELL SEPARATION TUBEBd Becton Dickinson Vacutainer Systems PreanalyticK874328L-PHENYLALANINE METHYL ESTER HYDROCHLORIDE PME REAE.I. Dupont DE Nemours & Co., Inc.K873185DYNABEADS HLA CELL PREP II ISOLATION PRODUCTDynal Biotech, Inc.K872775LEUCOPREP BRAND TUBEBd Becton Dickinson Vacutainer Systems PreanalyticK860354SEPRACELL LYMPHOCYTE SEPARATION MEDIUMSepratech Corporation C/O Keller and Heckman

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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