FDA 510(k)

SEPRACELL LYMPHOCYTE SEPARATION MEDIUM

K-Number: K860354 · 1986-04-18

ApplicantSepratech Corporation C/O Keller and Heckman

Decision Date1986-04-18

Product CodeJCF

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

SEPRACELL LYMPHOCYTE SEPARATION MEDIUM is the device name listed in this FDA 510(k) record. The listed applicant is Sepratech Corporation C/O Keller and Heckman. It received FDA 510(k) clearance on 1986-04-18 under 510(k) number K860354. 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 SEPRACELL LYMPHOCYTE SEPARATION MEDIUM?

SEPRACELL LYMPHOCYTE SEPARATION MEDIUM is a medical device that received FDA 510(k) clearance on 1986-04-18. The listed applicant is Sepratech Corporation C/O Keller and Heckman. The 510(k) number is K860354.

When did SEPRACELL LYMPHOCYTE SEPARATION MEDIUM receive FDA 510(k) clearance?

SEPRACELL LYMPHOCYTE SEPARATION MEDIUM received FDA 510(k) clearance on 1986-04-18, under 510(k) number K860354.

Who is the listed applicant for SEPRACELL LYMPHOCYTE SEPARATION MEDIUM?

The FDA 510(k) record lists Sepratech Corporation C/O Keller and Heckman as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SEPRACELL LYMPHOCYTE SEPARATION MEDIUM?

The FDA product code for SEPRACELL LYMPHOCYTE SEPARATION MEDIUM is JCF.

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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.