Medical Device Manufacturer · US , Westlake , OH

Accumed Intl., Inc.

12 submissions · 12 cleared · Since 1996
12
Total
12
Cleared
0
Denied

Accumed Intl., Inc. — FDA 510(k) Submissions

Accumed Intl., Inc. has submitted 12 FDA 510(k) premarket notifications since 1996, of which 12 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Manual Antimicrobial Susceptibility Test Systems, Panels, Test, Susceptibility, Antimicrobial, Device, Automated Cell-locating, Gram Positive Identification Panel, System, Blood Culturing . Use the specialty filter in the sidebar to narrow results.

12 devices
1–12 of 12
SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES
K984489 · JWY Manual Antimicrobial... · Microbiology
Feb 1999 61d
SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH GREPAFLOXACIN
K983306 · LTT Panels, Test,... · Microbiology
Dec 1998 88d
SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH SPARFLOXACIN
K983310 · JTT Susceptibility Test... · Microbiology
Dec 1998 87d
SENSITITRE 19 - 24 HOUR SUSCEPTIBILITY PLATES WITH LEVOFLOXACIN
K983309 · LTT Panels, Test,... · Microbiology
Dec 1998 84d
SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH TROVAFLOXACIN
K983301 · JWY Manual Antimicrobial... · Microbiology
Nov 1998 65d
TRACCELL 2000 SLIDE MAPPING SYSTEM
K982786 · JOY Device, Automated... · Hematology
Oct 1998 67d
GRAM POSITIVE AUTOIDENTIFICATION PLATES, SENSITITRE AP90
K972576 · LQL Gram Positive... · Microbiology
Jan 1998 196d
TRACCELL 2000 SLIDE MAPPING SYSTEM
K964689 · JOY Device, Automated... · Hematology
Aug 1997 269d
MODIFICATION OF EST CULTURE SYSTEM II - MYCO
K972756 · MDB System, Blood Culturing · Microbiology
Aug 1997 63d
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE MIC PLATE
K965190 · JWY Manual Antimicrobial... · Microbiology
Mar 1997 85d
SENSITITRE 18 HOUR SUSCEPTIBILITY PLATES
K960366 · LTT Panels, Test,... · Microbiology
Apr 1996 75d
SENSITITRE 18 HOUR SUSCEPTIBILITY PLATES
K960235 · JWY Manual Antimicrobial... · Microbiology
Mar 1996 70d
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