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JBB – Solubility, Hemoglobin, Abnormal
Solubility, Hemoglobin, Abnormal
FDA product code
JBB
· Class II (moderate risk) · 21 CFR 864.7825 ·
Hematology
2
510(k) clearances
0
PMA approvals
0
recalls
Manufacturers
Simmler, Inc.
1
Histo-Med, Inc.
1
510(k) clearances
510(k)
Device
Applicant
Decision
K932872
Sickle Cell Test Kit
JBB · Traditional
Histo-Med, Inc.
08/16/1993
SE
K895745
Sickle Cell Solubility Test Kit
JBB · Traditional
Simmler, Inc.
11/29/1989
SE