Pantex, Div. Bio-Analysis, Inc. - FDA 510(k) Cleared Devices
16
Total
16
Cleared
0
Denied
FDA 510(k) Regulatory Record - Pantex, Div. Bio-Analysis, Inc. Chemistry ✕
16 devices
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
Cleared
Oct 15, 1985
PANTEX DIRECT TESTOSTERONE COATED TUBE RADIOIMMUNO
Chemistry
28d
Cleared
Oct 15, 1985
PANTEX DIRECT ESTRADIOL COATED TUBE RADIOIMMUNOASS
Chemistry
28d
Cleared
Oct 04, 1985
PANTEX DIRECT DHEA-S COATED TUBE RADIOIMMUNOASSAY
Chemistry
17d
Cleared
Mar 27, 1981
17B ESTRADIOL
Chemistry
60d