Medical Device Manufacturer · US , Mchenry , IL

Remel Co.

137 submissions · 137 cleared · Since 1979
137
Total
137
Cleared
0
Denied

Remel Co. — FDA 510(k) Submissions

Remel Co. has submitted 137 FDA 510(k) premarket notifications since 1979, of which 137 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Discs, Strips And Reagents, Microorganism Differentiation, Stains, Microbiologic, Susceptibility Test Discs, Antimicrobial, Culture Media, Selective And Non-differential, Culture Media, Selective And Differential . Use the specialty filter in the sidebar to narrow results.

137 devices
1–25 of 137
BACTI-SWAB DRY
K013711 · LIO Device, Specimen Collection · Microbiology
Nov 2001 19d
A.C.T. I
K965149 · JSM Culture Media,... · Microbiology
Jan 1997 30d
A.C.T. IV
K965150 · JSM Culture Media,... · Microbiology
Jan 1997 30d
A.C.T. III
K965151 · JSM Culture Media,... · Microbiology
Jan 1997 30d
A.C.T. II
K965152 · JSM Culture Media,... · Microbiology
Jan 1997 30d
CALCOFLUOR WHITE STAIN KIT
K960090 · JTS Stains, Microbiologic · Microbiology
Mar 1996 68d
BACTIDROP CALCOFLUOR WHITE
K960095 · JTS Stains, Microbiologic · Microbiology
Mar 1996 68d
REMEL CEFEPIME 30 UG SUSCEPTIBILITY DISK
K955669 · JTN Susceptibility Test... · Microbiology
Feb 1996 72d
SYNERGY QUAD
K941443 · JSO Culture Media,... · Microbiology
Sep 1994 179d
BHI AGAR WITH VANCOMYCIN
K941444 · JSO Culture Media,... · Microbiology
Sep 1994 179d
BACTICARD STREP
K936021 · JTO Discs, Strips And... · Microbiology
May 1994 154d
RIM E.COLI 0157:H7 LATEX TEST
K933457 · GNA Antisera, All Types,... · Microbiology
Apr 1994 280d
BACTICARD CANDIDA
K935124 · JXB Kit, Identification, Yeast · Microbiology
Feb 1994 120d
BACTICARD E. COLI
K934986 · JTO Discs, Strips And... · Microbiology
Feb 1994 127d
REMEL CEFPROZIL 30 MCG SUSCEPTIBILITY DISK
K934100 · JTN Susceptibility Test... · Microbiology
Nov 1993 91d
BACTICARD STREP
K933514 · JTO Discs, Strips And... · Microbiology
Oct 1993 100d
REMEL AZITHROMLYCIN 15 MCG SUSCEPTIBILITY DISK
K933657 · JTN Susceptibility Test... · Microbiology
Oct 1993 93d
REMEL CLARITHROMYCIN 15 MCG SUSCEPTIBILITY DISK
K933118 · JTN Susceptibility Test... · Microbiology
Aug 1993 46d
ZINC PVA
K931383 · LIO Device, Specimen Collection · Microbiology
Jun 1993 89d
REMEL LORACARBEF 30 MCG SUSCEPTIBILITY DISK
K931799 · JTN Susceptibility Test... · Microbiology
Jun 1993 64d
REMEL CEFPODOXIME 10 MCG SUSCEPTIBILITY DISK
K931289 · JTN Susceptibility Test... · Microbiology
Jun 1993 82d
REMEL CEFMETAZOLE 30 MCG SUSCEPTIBILITY DISK
K931290 · JTN Susceptibility Test... · Microbiology
May 1993 69d
BACTIDROP(TM) MUCAP
K930878 · JTO Discs, Strips And... · Microbiology
May 1993 81d
REMEL ENOXACIN 10 MCG SUSCEPTIBILITY DISK
K925060 · JTN Susceptibility Test... · Microbiology
Dec 1992 58d
REMEL CEFACLOR 30MCG SUSCEPTIBILITY DISK
K924846 · JTN Susceptibility Test... · Microbiology
Nov 1992 63d

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