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FDA 510(k)

ANTI-CYTOKERATIN MONOCLONAL ANTIBODY

K-Number: K864893 · 1988-07-07

ApplicantBd Becton Dickinson Vacutainer Systems Preanalytic
Decision Date1988-07-07
Product CodeLYE
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ANTI-CYTOKERATIN MONOCLONAL ANTIBODY 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 1988-07-07 under 510(k) number K864893. The device is classified under product code LYE. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANTI-CYTOKERATIN MONOCLONAL ANTIBODY?

ANTI-CYTOKERATIN MONOCLONAL ANTIBODY is a medical device that received FDA 510(k) clearance on 1988-07-07. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. The 510(k) number is K864893.

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

ANTI-CYTOKERATIN MONOCLONAL ANTIBODY received FDA 510(k) clearance on 1988-07-07, under 510(k) number K864893.

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

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 ANTI-CYTOKERATIN MONOCLONAL ANTIBODY?

The FDA product code for ANTI-CYTOKERATIN MONOCLONAL ANTIBODY is LYE.

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Related Devices (Code: LYE)

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.

K881259MAK-6 MONOCLONAL ANTI-CYTOKERATIN COCKTAILTriton Biosciences, Inc.

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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