COULTER Z2 ANALYZER— 510(k) K991070

Substantially Equivalent

Coulter Corp.

FDA 510(k) clearance K991070 for COULTER Z2 ANALYZER, Substantially Equivalent on 1999-05-11. Applicant: Coulter Corp.. Device class: 2.

Clearance details

Applicant: Coulter Corp.
Product code: Code GKL
Device class: Class 2
Regulation: 21 CFR 864.5200
Advisory panel: Hematology
Date received: 1999-03-31
Decision date: 1999-05-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hialeah, FL, US

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