Atlas FDA

LKZ

2 FDA 510(k) clearances · Product code

FDA profile

Official device name
Red-Cell Count By Photometry
Device class
Class II (moderate risk)
Regulation
21 CFR 864.7100
Medical specialty
Hematology
Flags
Third-party review eligible
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RecordFirmDate
COMPUR* M1000 HEMOGLOBIN & ERYTHROCYTE (K833708)Worthington Diagnostic Systems1984-01-04
ERYTHROCYTE TEST (K832771)Bio-Analytics Laboratories, Inc.1983-10-28

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