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

FDA 510(k) Regulatory Record - Remel Co. Microbiology ✕

124 devices

1-12 of 124

1 2 3 4

Cleared Nov 26, 2001

Microbiology · 19d

Cleared Jan 22, 1997

Microbiology · 30d

Cleared Jan 22, 1997

Microbiology · 30d

Cleared Jan 22, 1997

Microbiology · 30d

Cleared Jan 22, 1997

Microbiology · 30d

Cleared Mar 19, 1996

CALCOFLUOR WHITE STAIN KIT

Microbiology · 68d

Cleared Mar 19, 1996

BACTIDROP CALCOFLUOR WHITE

Microbiology · 68d

Cleared Feb 23, 1996

REMEL CEFEPIME 30 UG SUSCEPTIBILITY DISK

Microbiology · 72d

Cleared Sep 19, 1994

Microbiology · 179d

Cleared Sep 19, 1994

BHI AGAR WITH VANCOMYCIN

Microbiology · 179d

Cleared May 20, 1994

BACTICARD STREP

Microbiology · 154d

Cleared Apr 20, 1994

RIM E.COLI 0157:H7 LATEX TEST

Microbiology · 280d

1 2 3 4

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