Medical Device Manufacturer · US , Mchenry , IL

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

15 submissions · 15 cleared · Since 1978

Recent clearances: OPTICOAT T4 EIA KIT, OPTICOAT T3 EIA KIT

15

Total

15

Cleared

0

Denied

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

14 devices

1-14 of 14

Cleared Feb 03, 1999

OPTICOAT T4 EIA KIT

Chemistry · 217d

Cleared Dec 22, 1998

OPTICOAT T3 EIA KIT

Chemistry · 214d

Cleared Oct 19, 1989

CORTISOL CLASP-BEAD EIA KIT

Chemistry · 43d

Cleared Aug 11, 1989

T3 CLASP-BEAD EIA KIT

Chemistry · 92d

Cleared May 22, 1989

T4 CLASP-BEAD EIA KIT

Chemistry · 34d

Cleared Oct 31, 1988

TBG 125I RIA KIT, RADIOIMMUNO. OF SERUM THYROXINE

Chemistry · 55d

Cleared Apr 13, 1987

PROGESTERONE CLASP RADIOIMMUNOASSAY KIT

Chemistry · 18d

Cleared Sep 25, 1986

Chemistry · 37d

Cleared Mar 17, 1986

ALDOSTERONE DIRECT RIA KIT

Chemistry · 101d

Cleared Jun 06, 1985

ESTRADIOL DIRECT RIA KIT

Chemistry · 51d

Cleared Feb 01, 1985

RADIOIMMUNOASSAY OF HUMAN SERUM PLASMA OR URINE TO

Chemistry · 56d

Cleared Sep 14, 1984

CORITSOL PREMIX RIA KIT

Chemistry · 49d

Cleared Aug 07, 1984

DHEA-S DIRECT RIA KIT

Chemistry · 36d

Cleared May 02, 1984

PROGESTERONE DIRECT RIA KIT-RADIOIMM

Chemistry · 30d