Cleared Traditional

COULTER Z 1

K952308 · Coulter Corp. · Hematology
Oct 1995
Decision
142d
Days
Class 2
Risk

About This 510(k) Submission

K952308 is an FDA 510(k) clearance for the COULTER Z 1, a Counter, Cell, Automated (particle Counter) (Class II — Special Controls, product code GKL), submitted by Coulter Corp. (Miami, US). The FDA issued a Cleared decision on October 6, 1995, 142 days after receiving the submission on May 17, 1995. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5200.

Submission Details

510(k) Number K952308 FDA.gov
FDA Decision Cleared SESE
Date Received May 17, 1995
Decision Date October 06, 1995
Days to Decision 142 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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