Cleared Traditional

DAKO MOUSE ANTI-HUMAN B-CELL, CD19/RPE-CY5, CLONE HD37

K980635 · Dako Corp. · Hematology
Jul 1998
Decision
153d
Days
Class 2
Risk

About This 510(k) Submission

K980635 is an FDA 510(k) clearance for the DAKO MOUSE ANTI-HUMAN B-CELL, CD19/RPE-CY5, CLONE HD37, a Counter, Differential Cell (Class II — Special Controls, product code GKZ), submitted by Dako Corp. (Carpinteria, US). The FDA issued a Cleared decision on July 22, 1998, 153 days after receiving the submission on February 19, 1998. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number K980635 FDA.gov
FDA Decision Cleared SESE
Date Received February 19, 1998
Decision Date July 22, 1998
Days to Decision 153 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GKZ — Counter, Differential Cell
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5220

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