HEMAVIEW DARKFIELD MICROSCOPE SYSTEM— 510(k) K885091

Name: FDA 510(k) clearance K885091
Creator: U.S. Food and Drug Administration
Published: 1989-06-13

Substantially Equivalent

Technalysis, Inc.

FDA 510(k) clearance K885091 for HEMAVIEW DARKFIELD MICROSCOPE SYSTEM, Substantially Equivalent on 1989-06-13. Applicant: Technalysis, Inc.. Device class: 1.

Clearance details

Applicant: Technalysis, Inc.
Product code: Code IBM
Device class: Class 1
Regulation: 21 CFR 864.3600
Advisory panel: Pathology
Date received: 1988-12-12
Decision date: 1989-06-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Laguna Hills, CA, US

Download summary PDF View on FDA.gov ↗

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