SPUNCRIT (MODEL DRC-40)— 510(k) K961803

Name: FDA 510(k) clearance K961803
Creator: U.S. Food and Drug Administration
Published: 1996-07-05

Substantially Equivalent

Micro Diagnostics Corp.

FDA 510(k) clearance K961803 for SPUNCRIT (MODEL DRC-40), Substantially Equivalent on 1996-07-05. Applicant: Micro Diagnostics Corp.. Device class: 2.

Clearance details

Applicant: Micro Diagnostics Corp.
Product code: Code GKG
Device class: Class 2
Regulation: 21 CFR 864.6400
Advisory panel: Hematology
Date received: 1996-05-09
Decision date: 1996-07-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bethlehem, PA, US

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