IGC · Class I · 21 CFR 864.4010

FDA Product Code IGC: Formalin-saline

Leading manufacturers include Incstar Corp..

2
Total
2
Cleared
245d
Avg days
1996
Since

FDA 510(k) Cleared Formalin-saline Devices (Product Code IGC)

2 devices
1–2 of 2
Cleared Jul 24, 1996
INCSTAR HSV I/II IGG FAST ELISA ASSAY
K955362
Incstar Corp.
Microbiology · 245d
Cleared Jul 24, 1996
INCSTAR HSZ I/II IGG ELISA ASSAY
K955363
Incstar Corp.
Microbiology · 245d

About Product Code IGC - Regulatory Context