Medical Device Manufacturer · US , Mchenry , IL

Biotecx Laboratories, Inc.

15 submissions · 15 cleared · Since 1978
15
Total
15
Cleared
0
Denied

Biotecx Laboratories, Inc. — FDA 510(k) Submissions

Biotecx Laboratories, Inc. has submitted 15 FDA 510(k) premarket notifications since 1978, of which 15 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Radioimmunoassay, Cortisol, Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine, Radioimmunoassay, Total Triiodothyronine, Radioimmunoassay, Progesterone, Radioimmunoassay, Dehydroepiandrosterone (free And Sulfate) . Use the specialty filter in the sidebar to narrow results.

15 devices
1–15 of 15
OPTICOAT T4 EIA KIT
K982298 · KLI Enzyme Immunoassay,... · Chemistry
Feb 1999 217d
OPTICOAT T3 EIA KIT
K981824 · CDP Radioimmunoassay, Total... · Chemistry
Dec 1998 214d
CORTISOL CLASP-BEAD EIA KIT
K895407 · CGR Radioimmunoassay, Cortisol · Chemistry
Oct 1989 43d
T3 CLASP-BEAD EIA KIT
K893620 · CDP Radioimmunoassay, Total... · Chemistry
Aug 1989 92d
T4 CLASP-BEAD EIA KIT
K892853 · KLI Enzyme Immunoassay,... · Chemistry
May 1989 34d
TBG 125I RIA KIT, RADIOIMMUNO. OF SERUM THYROXINE
K883765 · KHQ Radioassay,... · Chemistry
Oct 1988 55d
PROGESTERONE CLASP RADIOIMMUNOASSAY KIT
K871211 · JLS Radioimmunoassay,... · Chemistry
Apr 1987 18d
HPL RIA KIT
K863188 · JMX Ninhydrin, Nitrogen... · Chemistry
Sep 1986 37d
ALDOSTERONE DIRECT RIA KIT
K854876 · KQN Radioassay, Angiotensin... · Chemistry
Mar 1986 101d
ESTRADIOL DIRECT RIA KIT
K851540 · CHP Radioimmunoassay, Estradiol · Chemistry
Jun 1985 51d
RADIOIMMUNOASSAY OF HUMAN SERUM PLASMA OR URINE TO
K844767 · CGI Radioimmunoassay, Estriol · Chemistry
Feb 1985 56d
CORITSOL PREMIX RIA KIT
K842957 · CGR Radioimmunoassay, Cortisol · Chemistry
Sep 1984 49d
DHEA-S DIRECT RIA KIT
K842555 · JKC Radioimmunoassay,... · Chemistry
Aug 1984 36d
PROGESTERONE DIRECT RIA KIT-RADIOIMM
K841333 · JLS Radioimmunoassay,... · Chemistry
May 1984 30d
ELECTRO-PLETHYSMOGRAPH
K780761 · JOM Plethysmograph,... · Cardiovascular
Jun 1978 52d
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