TRACCELL 2000 SLIDE MAPPING SYSTEM— 510(k) K964689

Name: FDA 510(k) clearance K964689
Creator: U.S. Food and Drug Administration
Published: 1997-08-18

Substantially Equivalent

Accumed Intl., Inc.

FDA 510(k) clearance K964689 for TRACCELL 2000 SLIDE MAPPING SYSTEM, Substantially Equivalent on 1997-08-18. Applicant: Accumed Intl., Inc.. Device class: 2.

Clearance details

Applicant: Accumed Intl., Inc.
Product code: Code JOY
Device class: Class 2
Regulation: 21 CFR 864.5260
Advisory panel: Hematology
Date received: 1996-11-22
Decision date: 1997-08-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, US

Download summary PDF View on FDA.gov ↗

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