HEMATALL-C PLUS HEMATOLOGY CONTROLS— 510(k) K863224

Name: FDA 510(k) clearance K863224
Creator: U.S. Food and Drug Administration
Published: 1986-10-29

Substantially Equivalent

Fisher Scientific Co., LLC

FDA 510(k) clearance K863224 for HEMATALL-C PLUS HEMATOLOGY CONTROLS, Substantially Equivalent on 1986-10-29. Applicant: Fisher Scientific Co., LLC. Device class: 2.

Clearance details

Applicant: Fisher Scientific Co., LLC
Product code: Code JPK
Device class: Class 2
Regulation: 21 CFR 864.8625
Advisory panel: Hematology
Date received: 1986-08-21
Decision date: 1986-10-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orangeburg, NY, US

Download summary PDF View on FDA.gov ↗

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