Search FDA 510(k) Clearance Records

Cleared Apr 04, 1996

HICHEM GLUCOSE/HK REAGENT KIT

K960084 · CFR

Hi Chem, Inc.

Chemistry · 84d

Cleared May 15, 1995

HICHEM ALT REAGENT KIT

K951818 · CKA

Hi Chem, Inc.

Chemistry · 25d

Cleared Oct 04, 1994

HICHEM ENZYME VERIFIER KIT

K943684 · JJT

Hi Chem, Inc.

Chemistry · 67d

Cleared May 13, 1994

HICHEM CALCIUM REAGENT FOR THE SYNCHRON CX3 PROD. NO. 88808

K941764 · CJY

Hi Chem, Inc.

Chemistry · 45d

Cleared Jul 17, 1990

HI CHEM TOTAL PROTEIN/ALBUMIN SERUM RANGE LIN STND

K902673 · JJY

Hi Chem, Inc.

Chemistry · 29d

Cleared Oct 24, 1986

ION 2/4 FLOW CELL CLEANER (PRODUCT #88656)

K863617 · JGS

Hi Chem, Inc.

Chemistry · 38d

Cleared Jun 13, 1986

LDP REAGENT CARTRIDGE (NO. 88216)

K862027 · CFJ

Hi Chem, Inc.

Chemistry · 16d

Cleared Jun 05, 1986

GGT REAGENT CARTRIDGE (PRODUCT NO. 88204)

K861893 · JXL

Hi Chem, Inc.

Chemistry · 20d

Cleared May 29, 1986

CK REAGENT CARTRIDGE (PRODUCT NO. 88213)

K861879 · CGS

Hi Chem, Inc.

Chemistry · 14d

Cleared Apr 28, 1986

HI CHEM DIAGNOSTICS LDL REAGENT CARTRIDGE

K861419 · CFJ

Hi Chem, Inc.

Chemistry · 13d

Cleared Apr 28, 1986

AP REAGENT CARTRIDGE

K861284 · CJE

Hi Chem, Inc.

Chemistry · 21d

Cleared Apr 28, 1986

AST REAGENT CARTRIDGE

K861283 · CIT

Hi Chem, Inc.

Chemistry · 21d

Cleared Apr 28, 1986

ALT REAGENT CARTRIDGE (PRODUCT NO. 88210)

K861231 · CKA

Hi Chem, Inc.

Chemistry · 27d

Cleared Jan 22, 1986

CLEANING REAGENT KIT PRODUCT NO 88194

K855196 · JJE

Hi Chem, Inc.

Chemistry · 27d

Cleared Aug 29, 1985

HI-CHEM DIAGNOSTICS ENZYME RINSE CONCENTRATE

K852867 · CKA

Hi Chem, Inc.

Chemistry · 52d

Cleared Aug 06, 1985

HI CHEM DIAGNOSTICS CLEANING NEUTRALIZER SOL#88193

K853003 · JJE

Hi Chem, Inc.

Chemistry · 21d

Cleared Apr 29, 1985

ION 2 REAGENT KI

K851350 · CEM

Hi Chem, Inc.

Chemistry · 25d

Cleared Apr 01, 1985

CALIBRATOR B 88133

K850405 · JIX

Hi Chem, Inc.

Chemistry · 56d

Cleared Aug 16, 1984

HICHEM ION 2/4 URINE RANGE CALIBRATOR

K842450 · JIS

Hi Chem, Inc.

Chemistry · 55d

Cleared Aug 16, 1984

HICHEM ION 2/4 SERUM RANGE CALIBRATOR

K842449 · JIS

Hi Chem, Inc.

Chemistry · 55d

Cleared Jun 22, 1984

ION 4 SODIUM/POTASSIUM/CHLORIDE/TOTAL

K842025 · JGS

Hi Chem, Inc.

Chemistry · 35d

Cleared May 16, 1984

DIRECT BILIRUBIN REAGENT

K841572 · CIG

Hi Chem, Inc.

Chemistry · 29d

Cleared Nov 25, 1983

POTASSIUM ELECTRODE TIP ASSAMBLY-K-

K833159 · CEM

Hi Chem, Inc.

Chemistry · 70d

Cleared Jun 30, 1983

AMYLASE REAGENT #88129

K831295 · KHM

Hi Chem, Inc.

Chemistry · 71d