GMK · Class II · 21 CFR 866.3320

FDA Product Code GMK: Antiserum, Positive Control, Histoplasma Capsulatum

Leading manufacturers include Meridian Diagnostics, Inc. and I M, Inc..

9
Total
9
Cleared
27d
Avg days
1976
Since

FDA 510(k) Cleared Antiserum, Positive Control, Histoplasma Capsulatum Devices (Product Code GMK)

9 devices
1–9 of 9
Cleared Jan 24, 1980
IMMUNODIFFUSION BAND INTENSIFYING FLUID
K792692
Meridian Diagnostics, Inc.
Immunology · 28d
Cleared Jan 24, 1980
NEGATIVE CONTROL SERUM
K792694
Meridian Diagnostics, Inc.
Microbiology · 28d
Cleared Jan 17, 1980
HISTOPLASMA CAPSULATUM, ANTISERUM
K792679
Meridian Diagnostics, Inc.
Microbiology · 21d
Cleared Jan 17, 1980
HISTOPLASMA CAPSULATUM, ANTISERUM
K792718
Meridian Diagnostics, Inc.
Microbiology · 21d
Cleared Nov 01, 1976
ANTI-HISTOPLASMA CONTROL SERUM(MYCELIAL)
K760831
I M, Inc.
Immunology · 19d
Cleared Nov 01, 1976
ANTI-HISTOPLASMA CONTROL SERUM (YEAST)
K760832
I M, Inc.
Immunology · 19d

About Product Code GMK - Regulatory Context