HEMATACHEK— 510(k) K964452

Substantially Equivalent

Richmond Diagnostics, Inc.

FDA 510(k) clearance K964452 for HEMATACHEK, Substantially Equivalent on 1997-02-20. Applicant: Richmond Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Richmond Diagnostics, Inc.
Product code: Code GLK
Device class: Class 2
Regulation: 21 CFR 864.8625
Advisory panel: Hematology
Date received: 1996-11-06
Decision date: 1997-02-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Brunswick, NJ, US

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