Fetal Fibronectin Enzyme Immunoassay Kit (Eik)

FDA premarket approval P920048 · Enzyme Immunoassay, Fetal Fibronectin

PMA numberP920048

Approval

Applicant
Hologic, Inc.
Received
October 20, 1992
Decision date
September 21, 1995 (APPR)
Supplements
26, latest August 26, 2026
Product code
LKV – Enzyme Immunoassay, Fetal Fibronectin

Official FDA PMA record