OAM · Class I · 21 CFR 862.1550

FDA Product Code OAM: Immunoassay, Insulin-like Growth Factor Binding Protein-1

The Device Is A Qualitative Immunochromatographic Test For The Detection Of Amniotic Fluid In Cervicovaginal Secretions. The Test Is Intended For Professional Use To Help Diagnose The Rupture Of Fetal Membranes In Pregnant Women.

2
Total
2
Cleared
293d
Avg days
2007
Since

FDA 510(k) Cleared Immunoassay, Insulin-like Growth Factor Binding Protein-1 Devices (Product Code OAM)

2 devices
1–2 of 2
No devices found for this product code.

About Product Code OAM - Regulatory Context