Kallestad Diag, A Div. of Erbamont, Inc. - FDA 510(k) Cleared Devices
Recent clearances: QM300 CALIBRATOR G PACK, QM300 ANTISTREPTOLYSIN O (ASO) ANTIGEN PACK, QM300 CONTROL G PACK
58
Total
58
Cleared
0
Denied
FDA 510(k) Regulatory Record - Kallestad Diag, A Div. of Erbamont, Inc. Microbiology ✕
14 devices
Cleared
Jun 17, 1991
QM300 CALIBRATOR G PACK
Microbiology
105d
Cleared
Jun 17, 1991
QM300 ANTISTREPTOLYSIN O (ASO) ANTIGEN PACK
Microbiology
105d
Cleared
Jun 17, 1991
QM300 CONTROL G PACK
Microbiology
105d
Cleared
Jan 14, 1991
CHLAMYDIA SYSTEM SOFTWARE (CSS)
Microbiology
89d
Cleared
Jul 26, 1990
PATHFINDER(TM) CHLAMYDIA MICROPLATE KIT
Microbiology
66d
Cleared
Mar 23, 1990
PLATELIA TOXO IGG KIT
Microbiology
232d
Cleared
Mar 15, 1990
PLATELIA TOXO IGM KIT
Microbiology
224d
Cleared
Dec 21, 1989
PLATELIA RUBELLA IGG KIT
Microbiology
140d
Cleared
Nov 30, 1988
PATHFINDER(TM) CHLAMYDIA EIA DETECT KIT/MODIFIED
Microbiology
34d
Cleared
Apr 12, 1988
PATHFINDER(TM) CHLAMYDIA EIA DETECTION KIT
Microbiology
42d
Cleared
Mar 23, 1988
PATHFINDER(TM) CHLAMYDIA EIA BRUSH COLLECTION KIT
Microbiology
7d
Cleared
Mar 17, 1988
PATHFINDER(TM) DIRECT DETECTION SYS C. TRACHOMATIS
Microbiology
72d
Cleared
Apr 08, 1987
MODIFIED PATHFINDER SPECIMEN COLLECTION KIT
Microbiology
29d
Cleared
Feb 02, 1987
PATHFINDER CHLAMYDIA CULTURE CONFIRMATION SYSTEM
Microbiology
66d