FISHER DIAGNOSTICS HEMATALL-C CALIBRATOR— 510(k) K862318

Name: FDA 510(k) clearance K862318
Creator: U.S. Food and Drug Administration
Published: 1986-07-10

Substantially Equivalent

Fisher Scientific Co., LLC

FDA 510(k) clearance K862318 for FISHER DIAGNOSTICS HEMATALL-C CALIBRATOR, Substantially Equivalent on 1986-07-10. 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: 1986-06-18
Decision date: 1986-07-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orangeburg, NY, US

Download summary PDF View on FDA.gov ↗

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