Medical Device Manufacturer · US , Mchenry , IL

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

52 submissions · 52 cleared · Since 1977

Total

Cleared

Denied

Hi Chem, Inc. has 52 FDA 510(k) cleared chemistry devices. Based in Mchenry, US.

Historical record: 52 cleared submissions from 1977 to 1996.

Browse the complete list of FDA 510(k) cleared chemistry devices from this manufacturer. Filter by specialty or product code using the sidebar.

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

52 devices

1-12 of 52

Cleared Apr 04, 1996

HICHEM GLUCOSE/HK REAGENT KIT

K960084 · CFR

Chemistry · 84d

Cleared May 15, 1995

HICHEM ALT REAGENT KIT

K951818 · CKA

Chemistry · 25d

Cleared Oct 04, 1994

HICHEM ENZYME VERIFIER KIT

K943684 · JJT

Chemistry · 67d

Cleared May 13, 1994

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

K941764 · CJY

Chemistry · 45d

Cleared Jul 17, 1990

HI CHEM TOTAL PROTEIN/ALBUMIN SERUM RANGE LIN STND

K902673 · JJY

Chemistry · 29d

Cleared Oct 24, 1986

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

K863617 · JGS

Chemistry · 38d

Cleared Jun 13, 1986

LDP REAGENT CARTRIDGE (NO. 88216)

K862027 · CFJ

Chemistry · 16d

Cleared Jun 05, 1986

GGT REAGENT CARTRIDGE (PRODUCT NO. 88204)

K861893 · JXL

Chemistry · 20d

Cleared May 29, 1986

CK REAGENT CARTRIDGE (PRODUCT NO. 88213)

K861879 · CGS

Chemistry · 14d

Cleared Apr 28, 1986

ALT REAGENT CARTRIDGE (PRODUCT NO. 88210)

K861231 · CKA

Chemistry · 27d

Cleared Apr 28, 1986

AST REAGENT CARTRIDGE

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

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