GNM · Class I · 21 CFR 866.3145

FDA Product Code GNM: Antisera, Fluorescent, Coxsackievirus A 1-24, B 1-6

Leading manufacturers include Chemicon Intl., Inc. and Light Diagnostics.

9
Total
9
Cleared
612d
Avg days
1995
Since

FDA 510(k) Cleared Antisera, Fluorescent, Coxsackievirus A 1-24, B 1-6 Devices (Product Code GNM)

9 devices
1–9 of 9
Cleared Sep 08, 1995
ENTEROVIRUS MONOCL ANTIBODY DET OF COXSACKIE A9 VIRUS
K936073
Chemicon Intl., Inc.
Microbiology · 627d
Cleared Sep 08, 1995
COXSACKIE A24 VIRUS MONOCLONAL ANTIBODY
K936089
Chemicon Intl., Inc.
Microbiology · 626d
Cleared Sep 08, 1995
COXSACKIEVIRUS B1 MONOCLONAL ANTIBODY
K936145
Chemicon Intl., Inc.
Microbiology · 620d
Cleared Sep 08, 1995
COXSACKIEVIRUS B3 MONOCLONAL ANTIBODY
K936251
Light Diagnostics
Microbiology · 617d
Cleared Sep 08, 1995
COXSACKIEVIRUS B@ MONOCLONAL ANTIBODY
K936252
Light Diagnostics
Microbiology · 617d
Cleared Sep 08, 1995
COXSACKIEVIRUS B4 MONOCLONAL ANTIBODY
K936253
Light Diagnostics
Microbiology · 617d
Cleared Sep 08, 1995
COCKSACKIEVIRUS B6 MONOCLONAL ANTIBODY
K936254
Light Diagnostics
Microbiology · 617d
Cleared Sep 08, 1995
COXSACKIEVIRUS B BLEND MONOCLONAL ANTIBODIES
K940471
Chemicon Intl., Inc.
Microbiology · 583d
Cleared Sep 08, 1995
COXSACKIEVIRUS B5 MONOCLONAL ANTIBODY
K940472
Chemicon Intl., Inc.
Microbiology · 583d

About Product Code GNM - Regulatory Context