Medical Device Manufacturer · US , Mchenry , IL

Pantex, Div. Bio-Analysis, Inc.

16 submissions · 16 cleared · Since 1981
16
Total
16
Cleared
0
Denied

Pantex, Div. Bio-Analysis, Inc. — FDA 510(k) Submissions

Pantex, Div. Bio-Analysis, Inc. has submitted 16 FDA 510(k) premarket notifications since 1981, of which 16 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Radioimmunoassay, Luteinizing Hormone, Radioimmunoassay, Estradiol, Radioimmunoassay, Testosterones And Dihydrotestosterone, Radioimmunoassay, Cortisol, Radioassay, Triiodothyronine Uptake . Use the specialty filter in the sidebar to narrow results.

16 devices
1–16 of 16
PANTEX AM/PM SALIVARY CORTISOL ENZYME IMMUNOASSAY
K102841 · NHG Enzyme Immunoassay,... · Chemistry
May 2012 587d
NEOSCREEN ELISA TSH
K942658 · JLW Radioimmunoassay,... · Chemistry
Feb 1995 263d
PROLACTIN IRMA IMMUNOMAG
K914107 · CFT Radioimmunoassay,... · Chemistry
Sep 1991 17d
FSH IRMA IMMUNOMAG
K912804 · CGJ Radioimmunoassay,... · Chemistry
Aug 1991 48d
NEONATAL BLOOD SPOT TEST 17-HYDROXPROG RADIO KIT
K911839 · JLX Radioimmunoassay,... · Chemistry
Jun 1991 54d
LH IRMA IMMUNOMAG
K911050 · CEP Radioimmunoassay,... · Chemistry
Apr 1991 35d
PANTEX IRMA LH 1251 KIT
K910717 · CEP Radioimmunoassay,... · Chemistry
Mar 1991 27d
IMMUNOCOAT PROGESTERONE RADIOIMMUNOASSAY KIT
K894049 · JLS Radioimmunoassay,... · Chemistry
Sep 1989 93d
PANTEX FTE FREE TESTOSTERONE RADIOIMMUNOASSAY KIT
K862483 · CDZ Radioimmunoassay,... · Chemistry
Jan 1987 198d
PANCOAT T3 UPTAKE COATED TUBE RADIOIMMUNOASSAY KIT
K862447 · KHQ Radioassay,... · Chemistry
Oct 1986 102d
PANCOAT CORTISOL COATED TUBE RADIOIMMUNOASSAY KIT
K862336 · CGR Radioimmunoassay, Cortisol · Chemistry
Sep 1986 97d
PANCOAT T4 COATED TUBE RADIOIMMUNOASSAY KIT
K854324 · CDX Radioimmunoassay, Total... · Chemistry
Dec 1985 38d
PANTEX DIRECT TESTOSTERONE COATED TUBE RADIOIMMUNO
K853865 · CDZ Radioimmunoassay,... · Chemistry
Oct 1985 28d
PANTEX DIRECT ESTRADIOL COATED TUBE RADIOIMMUNOASS
K853866 · CHP Radioimmunoassay, Estradiol · Chemistry
Oct 1985 28d
PANTEX DIRECT DHEA-S COATED TUBE RADIOIMMUNOASSAY
K853867 · JKC Radioimmunoassay,... · Chemistry
Oct 1985 17d
17B ESTRADIOL
K810204 · CHP Radioimmunoassay, Estradiol · Chemistry
Mar 1981 60d
Filters
All16 Chemistry 16