Medical Device Manufacturer · US , Mchenry , IL

Remel Co. - FDA 510(k) Cleared Devices

137 submissions · 137 cleared · Since 1979
137
Total
137
Cleared
0
Denied
124 devices
101-124 of 124
Cleared Mar 08, 1983
UREA-PDA DISK
K830396 · JSS
Microbiology · 29d
Cleared Feb 28, 1983
LYSOSTAPHIN REAGENT SET
K830323 · JTO
Microbiology · 28d
Cleared Oct 06, 1981
GC DISK
K812698 · JTR
Microbiology · 14d
Cleared Aug 13, 1981
KANAMYCIN DISK
K812082 · JTO
Microbiology · 22d
Cleared Aug 13, 1981
BILE DISK
K812083 · JTO
Microbiology · 22d
Cleared Aug 13, 1981
SPS DISK
K812084 · JTO
Microbiology · 22d
Cleared Mar 17, 1981
BETA LYSIN DISK
K810541 · JTO
Microbiology · 18d
Cleared Feb 12, 1981
ACRIDINE ORANGE STAIN
K803304 · IDC
Microbiology · 44d
Cleared Jan 08, 1981
BUFFERED CHARCOAL YEAST EXTRACT AGAR
K802757 · JSJ
Microbiology · 65d
Cleared Dec 31, 1980
SELECTIVE CHARCOAL YEAST EXTRACT AGAR
K802758 · JSJ
Microbiology · 57d
Cleared Dec 22, 1980
SAF FIXATIVE
K803054 · IGB
Microbiology · 20d
Cleared Dec 16, 1980
CYE BIPHASIC BLOOD CULTURE MEDIUM
K802571 · JSJ
Microbiology · 60d
Cleared Oct 31, 1980
BHI AGAR/BHI BROTH BIPHASIC BLOOD CLT.BT
K802415 · JSG
Microbiology · 25d
Cleared Aug 13, 1980
PORPHYRIN (ALA) DISK
K801492 · JTO
Microbiology · 48d
Cleared Aug 13, 1980
ALA SWAB
K801493 · JTO
Microbiology · 48d
Cleared Jul 21, 1980
HIPPURATE DISK
K801305 · JTC
Microbiology · 48d
Cleared Jul 08, 1980
NITRATE SWAB-RAPID TEST
K800803 · JXB
Microbiology · 89d
Cleared May 08, 1980
RAPID FERMENTATION AGAR (RFA)
K800734 · JSE
Microbiology · 36d
Cleared May 02, 1980
CELLIBIOSE-ARGININE-LYSINE AGAR (CAL)
K800745 · JSI
Microbiology · 29d
Cleared Mar 19, 1980
CHARCOAL YEAST EXTRACT(CYE) AGAR
K792675 · JSJ
Microbiology · 83d
Cleared Mar 19, 1980
CEPH LACTAM DISK
K800287 · JSF
Microbiology · 37d
Cleared Jan 24, 1980
CAMPY THIO
K792676 · JSJ
Microbiology · 28d
Cleared Dec 07, 1979
COAGULASE PLASMA
K792235 · JTL
Microbiology · 31d
Cleared Jan 26, 1979
DISK, BETA-LACTAM
K790038 · JTO
Microbiology · 18d

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