Cleared Traditional

MOUSE IGG1 NEGATIVE CONTROLS

K991454 · Dako Corp. · Hematology
Jun 1999
Decision
56d
Days
Class 2
Risk

About This 510(k) Submission

K991454 is an FDA 510(k) clearance for the MOUSE IGG1 NEGATIVE CONTROLS, a Counter, Differential Cell (Class II — Special Controls, product code GKZ), submitted by Dako Corp. (Carpinteria, US). The FDA issued a Cleared decision on June 21, 1999, 56 days after receiving the submission on April 26, 1999. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number K991454 FDA.gov
FDA Decision Cleared SESE
Date Received April 26, 1999
Decision Date June 21, 1999
Days to Decision 56 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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