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Device Classification
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GJZ — Cyanomethemoglobin Reagent And Standard Solution
Class II
FDA Device Classification
Classification Details
Product Code
GJZ
Device Class
Class II
Regulation Number
864.7500
Submission Type
Review Panel
HE
Medical Specialty
Hematology
Implant
No
Recent 510(k) Clearances
K-Number
Applicant
Device Name
Date
K883683
tech-co
HEMOGLOBIN
October 6, 1988
K881242
abbott diagnostics
CELL-DYN RAPID-LYSE AND HEMOGLOBLIN
April 21, 1988