Remel Co. - FDA 510(k) Cleared Devices
137
Total
137
Cleared
0
Denied
124 devices
Cleared
Mar 08, 1983
UREA-PDA DISK
Microbiology
29d
Cleared
Feb 28, 1983
LYSOSTAPHIN REAGENT SET
Microbiology
28d
Cleared
Oct 06, 1981
GC DISK
Microbiology
14d
Cleared
Aug 13, 1981
KANAMYCIN DISK
Microbiology
22d
Cleared
Aug 13, 1981
BILE DISK
Microbiology
22d
Cleared
Aug 13, 1981
SPS DISK
Microbiology
22d
Cleared
Mar 17, 1981
BETA LYSIN DISK
Microbiology
18d
Cleared
Feb 12, 1981
ACRIDINE ORANGE STAIN
Microbiology
44d
Cleared
Jan 08, 1981
BUFFERED CHARCOAL YEAST EXTRACT AGAR
Microbiology
65d
Cleared
Dec 31, 1980
SELECTIVE CHARCOAL YEAST EXTRACT AGAR
Microbiology
57d
Cleared
Dec 22, 1980
SAF FIXATIVE
Microbiology
20d
Cleared
Dec 16, 1980
CYE BIPHASIC BLOOD CULTURE MEDIUM
Microbiology
60d
Cleared
Oct 31, 1980
BHI AGAR/BHI BROTH BIPHASIC BLOOD CLT.BT
Microbiology
25d
Cleared
Aug 13, 1980
PORPHYRIN (ALA) DISK
Microbiology
48d
Cleared
Aug 13, 1980
ALA SWAB
Microbiology
48d
Cleared
Jul 21, 1980
HIPPURATE DISK
Microbiology
48d
Cleared
Jul 08, 1980
NITRATE SWAB-RAPID TEST
Microbiology
89d
Cleared
May 08, 1980
RAPID FERMENTATION AGAR (RFA)
Microbiology
36d
Cleared
May 02, 1980
CELLIBIOSE-ARGININE-LYSINE AGAR (CAL)
Microbiology
29d
Cleared
Mar 19, 1980
CHARCOAL YEAST EXTRACT(CYE) AGAR
Microbiology
83d
Cleared
Mar 19, 1980
CEPH LACTAM DISK
Microbiology
37d
Cleared
Jan 24, 1980
CAMPY THIO
Microbiology
28d
Cleared
Dec 07, 1979
COAGULASE PLASMA
Microbiology
31d
Cleared
Jan 26, 1979
DISK, BETA-LACTAM
Microbiology
18d
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