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JBB

2 FDA 510(k) clearances · Product code

FDA profile

Official device name
Solubility, Hemoglobin, Abnormal
Device class
Class II (moderate risk)
Regulation
21 CFR 864.7825
Medical specialty
Hematology
Flags
Third-party review eligible
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RecordFirmDate
SICKLE CELL TEST KIT (K932872)Histo-Med, Inc.1993-08-16
SICKLE CELL SOLUBILITY TEST KIT (K895745)Simmler, Inc.1989-11-29

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