Hichem Diagnostics - FDA 510(k) Cleared Devices

Cleared Nov 13, 1989

HI CHEM TRIGLYCERIDES CALIBRATOR E (88185)

K895585 · JIS

Chemistry · 59d

Cleared Oct 23, 1989

HI CHEM CALIBRATOR A+

K895135 · JIX

Chemistry · 68d

Cleared May 09, 1989

HI CHEM CREATININE REAGENT (PRODUCT #88809)

K890671 · CGX

Chemistry · 89d

Cleared Apr 18, 1989

HI CHEM INORGANIC PHOSPHORUS REAGENT KIT #88196

K890773 · CEO

Chemistry · 62d

Cleared Apr 10, 1989

HI CHEM CALCIUM REAGENT #88808

K890584 · CJY

Chemistry · 63d

Cleared Apr 10, 1989

EXTEND INTENDED USE FOR ENZYME RINSE CONCENTRATE

K890990 · CHH

Chemistry · 42d

Cleared Mar 13, 1989

HI CHEM CALIBRATION STANDARDS LEVELS 1 AND 2

K890583 · JIX

Chemistry · 35d

Cleared Mar 10, 1989

HI CHEM WASH CONCENTRATE REAGENT #88805

K890578 · JQW

Chemistry · 32d

Cleared Feb 07, 1989

MODIFIED INTENDED USE ON CLEANING NEUTRALIZER SOL.

K890183 · JJE

Chemistry · 20d

Cleared Feb 07, 1989

MODIFIED INTENDED USE OF CLEANING REAGENT KIT

K890184 · JJE

Chemistry · 20d

Cleared Oct 31, 1988

HI CHEM KINETIC CHOLESTEROL REAGENT #88218

K883844 · CHH

Chemistry · 49d

Cleared Sep 13, 1988

URIC ACID REAGENT (PRODUCT #88219)

K883404 · KNK

Chemistry · 33d

Cleared Sep 13, 1988

TRIGLYCERIDES REAGENT (PRODUCT #88218)

K883405 · CDT

Chemistry · 33d

Cleared Jul 06, 1988

CHLORIDE/TOTAL CO2 SERUM RANGE LINEARITY STANDARDS

K881437 · JJY

Chemistry · 92d

Cleared Jul 06, 1988

UREA/GLUCOSE/CREATININE SERUM RANGE LINEARITY STAN

K881438 · JJY

Chemistry · 92d

Cleared Jun 02, 1988

SODIUM/POTASSIUM SERUM RANGE LINEARITY STANDARDS

K881436 · JJY

Chemistry · 58d