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FDA 510(k)

LYMPHO SEP(TM)

K-Number: K902445 · 1990-08-22

ApplicantIcn Biomedicals, Inc.
Decision Date1990-08-22
Product CodeJCF
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

LYMPHO SEP(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Icn Biomedicals, Inc.. It received FDA 510(k) clearance on 1990-08-22 under 510(k) number K902445. 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 LYMPHO SEP(TM)?

LYMPHO SEP(TM) is a medical device that received FDA 510(k) clearance on 1990-08-22. The listed applicant is Icn Biomedicals, Inc.. The 510(k) number is K902445.

When did LYMPHO SEP(TM) receive FDA 510(k) clearance?

LYMPHO SEP(TM) received FDA 510(k) clearance on 1990-08-22, under 510(k) number K902445.

Who is the listed applicant for LYMPHO SEP(TM)?

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

What is the FDA product code for LYMPHO SEP(TM)?

The FDA product code for LYMPHO SEP(TM) is JCF.

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Other records listing Icn Biomedicals, Inc. as applicant

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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.

K911731LEUCOPREP(R) BRAND CELL SEPARAT TUBE W/SODIUM CITRBd Becton Dickinson Vacutainer Systems PreanalyticK891407LEUCOPREP 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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