Medical Device Manufacturer · US , Mchenry , IL

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

70 submissions · 70 cleared · Since 1977

Recent clearances: RETIC-CHEX FOR CELL-DYN, CYTO-CHEX BCT, A1C-CELLULAR

70

Total

70

Cleared

0

Denied

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

17 devices

1-17 of 17

Cleared Mar 02, 2004

Chemistry · 55d

Cleared Jun 29, 2000

Chemistry · 52d

Cleared Jul 22, 1998

CHEM-CHEX STAT (NEW)

Chemistry · 23d

Cleared May 15, 1996

Chemistry · 49d

Cleared Jan 28, 1993

SUGAR CHEX LINEARITY FOR THE ONE TOUCH

Chemistry · 147d

Cleared Mar 23, 1992

CHEM-CHEM MULTI-ANALYTE (MODIFIED)

Chemistry · 59d

Cleared Sep 19, 1991

Chemistry · 31d

Cleared Dec 26, 1990

CHEM-CHEX LIPID

Chemistry · 26d

Cleared Aug 09, 1990

Chemistry · 22d

Cleared Jul 16, 1990

CHEM-CHEX BILIRUBIN

Chemistry · 17d

Cleared Apr 16, 1990

Chemistry · 45d

Cleared Sep 16, 1987

REFLO-CHEX, A CHOLESTEROL REFERENCE CONTROL

Chemistry · 40d

Cleared Apr 29, 1985

Chemistry · 46d

Cleared Apr 29, 1985

Chemistry · 46d

Cleared Feb 11, 1980

PIPET CALIBRATION KIT

Chemistry · 31d

Cleared Oct 10, 1978

Chemistry · 22d

Cleared Jun 06, 1978

Chemistry · 29d