Cleared Traditional

COULTER Z2 ANALYZER

K991070 · Coulter Corp. · Hematology
May 1999
Decision
41d
Days
Class 2
Risk

About This 510(k) Submission

K991070 is an FDA 510(k) clearance for the COULTER Z2 ANALYZER, a Counter, Cell, Automated (particle Counter) (Class II — Special Controls, product code GKL), submitted by Coulter Corp. (Hialeah, US). The FDA issued a Cleared decision on May 11, 1999, 41 days after receiving the submission on March 31, 1999. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5200.

Submission Details

510(k) Number K991070 FDA.gov
FDA Decision Cleared SESE
Date Received March 31, 1999
Decision Date May 11, 1999
Days to Decision 41 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GKL — Counter, Cell, Automated (particle Counter)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5200

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