Medical Device Manufacturer · US , Mchenry , IL

Marion Laboratories, Inc. - FDA 510(k) Cleared Devices

38 submissions · 34 cleared · Since 1978

38

Total

34

Cleared

0

Denied

FDA 510(k) Regulatory Record - Marion Laboratories, Inc. Microbiology ✕

18 devices

1-12 of 18

Cleared Apr 14, 1987

CULTURETTE BRAND CDT CLOSTRIDIUM DIFFICILE TEST

Microbiology · 42d

Cleared Sep 17, 1986

MODIFICATION OF CDT(TM) CLOSTRIDIUM TEST

Microbiology · 8d

Cleared Jun 16, 1986

BIOSPHERE ANAEROBIC ENVIRONMENTAL DEVICE

Microbiology · 13d

Cleared Aug 01, 1985

CULTURETTE BRAND 10-MINUTE GROUP A STREP I.D.

Microbiology · 9d

Cleared Jul 19, 1985

CULTURETTE BRAND RAPID LATEX TEST CLOSTRIDIUM TOXI

Microbiology · 71d

Cleared Jun 04, 1985

Microbiology · 56d

Cleared Mar 05, 1985

BIO-BAG ENVIRONMENTAL CHAMBER -TYPE A-MULTI-PLATE

Microbiology · 69d

Cleared Apr 08, 1983

ARTIMICROBIAL REMOVAL DEVICE

Microbiology · 63d

Cleared Mar 01, 1983

BAC-T-SCREEN BACTERIURIA DETECTION DEV

Microbiology · 70d

Cleared Aug 25, 1982

ANTIMICROBIAL REMOVAL DEVICE (ARD)

Microbiology · 20d

Cleared Apr 29, 1981

BIO-BAG TM ENVIRONMENTAL CHAMBER TYPE M

Microbiology · 12d

Cleared Apr 03, 1981

ANTIMICROBIAL REMOVAL DEVICE

Microbiology · 28d