Medical Device Manufacturer · US , Mchenry , IL

Hi Chem, Inc. - FDA 510(k) Cleared Devices

52 submissions · 52 cleared · Since 1977

52

Total

52

Cleared

0

Denied

FDA 510(k) Regulatory Record - Hi Chem, Inc. Chemistry ✕

50 devices

1-12 of 50

Cleared Apr 04, 1996

HICHEM GLUCOSE/HK REAGENT KIT

Chemistry · 84d

Cleared May 15, 1995

HICHEM ALT REAGENT KIT

Chemistry · 25d

Cleared Oct 04, 1994

HICHEM ENZYME VERIFIER KIT

Chemistry · 67d

Cleared May 13, 1994

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

Chemistry · 45d

Cleared Jul 17, 1990

HI CHEM TOTAL PROTEIN/ALBUMIN SERUM RANGE LIN STND

Chemistry · 29d

Cleared Oct 24, 1986

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

Chemistry · 38d

Cleared Jun 13, 1986

LDP REAGENT CARTRIDGE (NO. 88216)

Chemistry · 16d

Cleared Jun 05, 1986

GGT REAGENT CARTRIDGE (PRODUCT NO. 88204)

Chemistry · 20d

Cleared May 29, 1986

CK REAGENT CARTRIDGE (PRODUCT NO. 88213)

Chemistry · 14d

Cleared Apr 28, 1986

ALT REAGENT CARTRIDGE (PRODUCT NO. 88210)

Chemistry · 27d

Cleared Apr 28, 1986

AST REAGENT CARTRIDGE

Chemistry · 21d

Cleared Apr 28, 1986

AP REAGENT CARTRIDGE

Chemistry · 21d

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