Anti-Cytokeratin Monoclonal Antibody

FDA 510(k) K864893 · Bd Becton Dickinson Vacutainer Systems Preanalytic

Substantially Equivalent

510(k) numberK864893

Submission

Device name
Anti-Cytokeratin Monoclonal Antibody
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic
Franklin Lakes, NJ, US
Received
December 15, 1986
Decision date
July 7, 1988
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
LYE – Cytokeratins
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5550
Specialty
Immunology

Other 510(k)s with product code LYE

510(k)DeviceApplicantDecision
K881259MAK-6 Monoclonal Anti-Cytokeratin CocktailLYE · Traditional Triton Biosciences, Inc.10/12/1988SE

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Questions and answers

When was Anti-Cytokeratin Monoclonal Antibody cleared by the FDA?

Anti-Cytokeratin Monoclonal Antibody (K864893) received a 510(k) decision of Substantially Equivalent on July 7, 1988, 570 days after the submission was received.

What is the product code of K864893?

The FDA product code is LYE – Cytokeratins, a Class II (moderate risk) device regulated under 21 CFR 866.5550.