GOM · Class II · 21 CFR 866.3510

FDA Product Code GOM: Antisera, Cf, Rubella

Leading manufacturers include Pyramid Biological Corp..

2
Total
2
Cleared
102d
Avg days
1995
Since

FDA 510(k) Cleared Antisera, Cf, Rubella Devices (Product Code GOM)

2 devices
1–2 of 2
Cleared Dec 20, 1995
ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA
K954515
Pyramid Biological Corp.
Microbiology · 83d
Cleared Dec 14, 1995
ENZYME LINKED UMMINOABSORBENT ASSAY, RUBELLA
K953826
Pyramid Biological Corp.
Microbiology · 121d

About Product Code GOM - Regulatory Context