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.

Leading manufacturers include Medix Biochemica and Alere Scarborough, Inc..

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
Cleared Jan 09, 2014
ACTIM PROM
K123986
Alere Scarborough, Inc.
Chemistry · 379d
Cleared Jan 25, 2007
ACTIM PROM AND CONTROLS
K061886
Medix Biochemica
Chemistry · 206d

About Product Code OAM - Regulatory Context