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510(k) K881259

MAK-6 MONOCLONAL ANTI-CYTOKERATIN COCKTAIL by Triton Biosciences, Inc. — Product Code LYE

K881259 is an FDA 510(k) premarket notification submitted by Triton Biosciences, Inc. for the device "MAK-6 MONOCLONAL ANTI-CYTOKERATIN COCKTAIL". The FDA issued a decision of Substantially Equivalent on October 12, 1988. The device falls under product code LYE (Cytokeratins), a Class II device regulated under 21 CFR 866.5550.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 12, 1988
Date Received
March 23, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cytokeratins
Device Class
Class II
Regulation Number
866.5550
Review Panel
PA
Submission Type

Other clearances for product code LYE

  • K864893 — ANTI-CYTOKERATIN MONOCLONAL ANTIBODY (July 7, 1988)

FDA data resources