Medical Device Manufacturer · US , Mchenry , IL

Biological & Environmental Control Laboratories - FDA 510(k) Cleared ...

20 submissions · 20 cleared · Since 1982

Recent clearances: ACCESS SYSTEMS NEEDLELESS VIAL ADAPTER, SAFE MATE I.V. EXTENSION SETS, SAFE MATE I.V. FLUID DELIVERY SETS

20

Total

20

Cleared

0

Denied

FDA 510(k) Regulatory Record - Biological & Environmental Control Laboratories General Hospital ✕

8 devices

1-8 of 8

Cleared Aug 18, 1997

ACCESS SYSTEMS NEEDLELESS VIAL ADAPTER

General Hospital · 116d

Cleared Aug 28, 1996

SAFE MATE I.V. EXTENSION SETS

General Hospital · 41d

Cleared Aug 28, 1996

SAFE MATE I.V. FLUID DELIVERY SETS

General Hospital · 41d

Cleared May 30, 1996

BEC SHROUDED PLASTIC CANNULA

General Hospital · 52d

Cleared May 15, 1996

BEC NEEDLELESS INJECTION SITE

General Hospital · 37d

Cleared Dec 04, 1984

SHAVE PREP KITS

General Hospital · 127d

Cleared Dec 04, 1984

WET SKIN SCRUB TRAY STERILE WET SKIN SCRUB KIT

General Hospital · 35d

Cleared Aug 17, 1984

SKIN SCRUB TRAY STERILE SKIN SCRUB KIT

General Hospital · 52d