Medical Device Manufacturer · US , Lenexa , KS

Remel, L.P. - FDA 510(k) Cleared Devices

10 submissions · 10 cleared · Since 1996

10

Total

10

Cleared

0

Denied

FDA 510(k) Regulatory Record - Remel, L.P. Microbiology ✕

10 devices

1-10 of 10

Cleared Aug 28, 1997

REMEL BILE ESCULIN AZIDE AGAR W/6 MCG/ML VANCOMYCIN

Microbiology · 64d

Cleared Feb 07, 1997

REMEL STAPH LATEX KIT

Microbiology · 101d

Cleared Dec 06, 1996

REMEL MEROPENEM 10UG SUSCEPTIBILITY DISK

Microbiology · 66d

Cleared Sep 18, 1996

10B ARGININE BROTH

Microbiology · 187d

Cleared Jul 30, 1996

RPR LIQUID CONTROLS

Microbiology · 260d

Cleared Jul 29, 1996

RPR CARD TEST KIT

Microbiology · 259d

Cleared Jul 10, 1996

GENTAMICIN DISK (120MCG)

Microbiology · 61d

Cleared Jul 10, 1996

STREPTOMYCIN DISK (300MCG)

Microbiology · 61d

Cleared Mar 25, 1996

MUELLER HINTON AGAR WITH 2% NACI

Microbiology · 63d

Cleared Feb 16, 1996

GC BASE W/ 1% GCHI

Microbiology · 108d