Medical Device Manufacturer · US , Mchenry , IL

Wampole Laboratories - FDA 510(k) Cleared Devices

12 submissions · 12 cleared · Since 1976

Total

Cleared

Denied

Wampole Laboratories has 12 FDA 510(k) cleared medical devices. Based in Mchenry, US.

Historical record: 12 cleared submissions from 1976 to 1997. Primary specialty: Immunology.

Browse the FDA 510(k) cleared devices submitted by Wampole Laboratories Filter by specialty or product code using the sidebar.

Wampole Laboratories is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Wampole Laboratories

12 devices

1-12 of 12

Cleared Mar 26, 1997

BORRELIA BURGDORFERI IGM ELISA TEST SYSTEM

K965129 · LSR

Microbiology · 93d

Cleared Mar 26, 1997

BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM

K965131 · LSR

Microbiology · 93d

Cleared Aug 30, 1991

RUBELLA VIRUS IMMUNOLOGICAL TEST SYSTEM

VIROGEN CMV ANTIBODY TEST

K875101 · LQO

Microbiology · 82d

Cleared Feb 17, 1988

MAT (TM) MICROALBUMIN TEST

INDIRECT FLUORESCENT (IFA-ANA)

K760681 · DHN

Immunology · 31d

Wampole Laboratories - FDA 510(k) Cleared Devices

FDA 510(k) Regulatory Record - Wampole Laboratories

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