FDA 510(k)

MONOCLONAL ANTIBODY ANTI-CD2

K-Number: K901187 · 1991-10-31

Decision Date1991-10-31

Product CodeGKZ

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

MONOCLONAL ANTIBODY ANTI-CD2 is the device name listed in this FDA 510(k) record. The listed applicant is Sigma Chemical Co.. It received FDA 510(k) clearance on 1991-10-31 under 510(k) number K901187. The device is classified under product code GKZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MONOCLONAL ANTIBODY ANTI-CD2?

MONOCLONAL ANTIBODY ANTI-CD2 is a medical device that received FDA 510(k) clearance on 1991-10-31. The listed applicant is Sigma Chemical Co.. The 510(k) number is K901187.

When did MONOCLONAL ANTIBODY ANTI-CD2 receive FDA 510(k) clearance?

MONOCLONAL ANTIBODY ANTI-CD2 received FDA 510(k) clearance on 1991-10-31, under 510(k) number K901187.

Who is the listed applicant for MONOCLONAL ANTIBODY ANTI-CD2?

The FDA 510(k) record lists Sigma Chemical Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MONOCLONAL ANTIBODY ANTI-CD2?

The FDA product code for MONOCLONAL ANTIBODY ANTI-CD2 is GKZ.

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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.