Medical Device Manufacturer · US , Mchenry , IL

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

13 submissions · 13 cleared · Since 1977

13

Total

13

Cleared

0

Denied

FDA 510(k) Regulatory Record - Wien Laboratories, Inc. Chemistry ✕

9 devices

1-9 of 9

Cleared Aug 12, 1991

Chemistry · 45d

Cleared Feb 04, 1984

PROGESTERONE TEST SET 125I 17-OH

Chemistry · 59d

Cleared Sep 12, 1983

ANDROSTENEDIONE TEST SET 125I

Chemistry · 49d

Cleared Nov 29, 1982

125 I-DEHYDROEPIANDROSTERONE SULFATE

Chemistry · 34d

Cleared Jun 14, 1982

DOXEPIN TRI-CY TEST SET

Chemistry · 11d

Cleared Jun 14, 1982

PROTRIPTYLINE TRI-CY TEST SET

Chemistry · 11d

Cleared Dec 11, 1980

125I-TESTOSTERONE TEST SET

Chemistry · 38d

Cleared Oct 30, 1979

DHEA-SULFATE TEST SET

Chemistry · 18d

Cleared Oct 21, 1977

17-HYDROXYPROGESTERONE TEST SET

Chemistry · 37d