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LYE – Cytokeratins
Cytokeratins
FDA product code
LYE
· Class II (moderate risk) · 21 CFR 866.5550 ·
Immunology
2
510(k) clearances
0
PMA approvals
0
recalls
Manufacturers
Bd Becton Dickinson Vacutainer Systems Preanalytic
1
Triton Biosciences, Inc.
1
510(k) clearances
510(k)
Device
Applicant
Decision
K881259
MAK-6 Monoclonal Anti-Cytokeratin Cocktail
LYE · Traditional
Triton Biosciences, Inc.
10/12/1988
SE
K864893
Anti-Cytokeratin Monoclonal Antibody
LYE · Traditional
Bd Becton Dickinson Vacutainer Systems Preanalytic
07/07/1988
SE