Medical Device Manufacturer · US , Mchenry , IL

Pantex, Div. Bio-Analysis, Inc. - FDA 510(k) Cleared Devices

16 submissions · 16 cleared · Since 1981

Recent clearances: PANTEX AM/PM SALIVARY CORTISOL ENZYME IMMUNOASSAY, NEOSCREEN ELISA TSH

16

Total

16

Cleared

0

Denied

FDA 510(k) Regulatory Record - Pantex, Div. Bio-Analysis, Inc. Chemistry ✕

16 devices

1-12 of 16

Cleared May 08, 2012

PANTEX AM/PM SALIVARY CORTISOL ENZYME IMMUNOASSAY

Chemistry · 587d

Cleared Feb 24, 1995

NEOSCREEN ELISA TSH

Chemistry · 263d

Cleared Sep 30, 1991

PROLACTIN IRMA IMMUNOMAG

Chemistry · 17d

Cleared Aug 12, 1991

FSH IRMA IMMUNOMAG

Chemistry · 48d

Cleared Jun 18, 1991

NEONATAL BLOOD SPOT TEST 17-HYDROXPROG RADIO KIT

Chemistry · 54d

Cleared Apr 12, 1991

LH IRMA IMMUNOMAG

Chemistry · 35d

Cleared Mar 19, 1991

PANTEX IRMA LH 1251 KIT

Chemistry · 27d

Cleared Sep 08, 1989

IMMUNOCOAT PROGESTERONE RADIOIMMUNOASSAY KIT

Chemistry · 93d

Cleared Jan 14, 1987

PANTEX FTE FREE TESTOSTERONE RADIOIMMUNOASSAY KIT

Chemistry · 198d

Cleared Oct 07, 1986

PANCOAT T3 UPTAKE COATED TUBE RADIOIMMUNOASSAY KIT

Chemistry · 102d

Cleared Sep 25, 1986

PANCOAT CORTISOL COATED TUBE RADIOIMMUNOASSAY KIT

Chemistry · 97d

Cleared Dec 05, 1985

PANCOAT T4 COATED TUBE RADIOIMMUNOASSAY KIT

Chemistry · 38d