Formalin-Saline

FDA product code IGC · Class I (low risk) · 21 CFR 864.4010 · Pathology

2510(k) clearances
0PMA approvals
0recalls
GMP exemptexempt from GMP rules

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K955363Incstar HSZ I/Ii Igg Elisa AssayIGC · Traditional Incstar Corp.07/24/1996SE
K955362Incstar HSV I/Ii Igg Fast Elisa AssayIGC · Traditional Incstar Corp.07/24/1996SE