Medical Device Manufacturer · US , Brea , CA

Hichem Diagnostics - FDA 510(k) Cleared Devices

41 submissions · 41 cleared · Since 1988

Total

Cleared

Denied

Hichem Diagnostics has 41 FDA 510(k) cleared chemistry devices. Based in Brea, US.

Historical record: 41 cleared submissions from 1988 to 1998.

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

Hichem Diagnostics is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Hichem Diagnostics

41 devices

1-12 of 41

Cleared Jul 29, 1998

HICHEM CALCIUM REAGENT KIT

K981794 · CJY

Chemistry · 69d

Cleared Sep 23, 1996

HICHEM ALP/AMP REAGENT KIT

K963383 · CKF

Chemistry · 27d

Cleared Sep 06, 1995

HICHEM ISE DILUENT KIT 70008

K953860 · CGZ

Chemistry · 20d

Cleared Sep 06, 1995

HICHEM ISE INTDERNAL REFERENCE KIT 70009

K953861 · CGZ

Chemistry · 20d

Cleared Sep 06, 1995

HICHEM ISEKCI SOLUTION KIT 70010

K953862 · CGZ

Chemistry · 20d

Cleared Sep 06, 1995

HICHEM ISE STANDARDS KIT 70011

K953863 · JIX

Chemistry · 20d

Cleared Aug 02, 1995

HICHEM AST REAGENT KIT

K951751 · CIT

Chemistry · 107d

Cleared May 02, 1995

HICHEM Y-GT REAGENT KIT

K946192 · JQB

Chemistry · 133d

Cleared Feb 23, 1995

HICHEM LDH/L REAGENT KIT

K946022 · CFJ

Chemistry · 73d

Cleared Aug 02, 1994

HI CHEM AQUEOUS GLUCOSE CONTROL, LOW, MED, HIGH

K941433 · JJX

Chemistry · 131d

Cleared Apr 20, 1993

HI CHEM BUN REAGENT KIT,PRODUCT NUMBER 88806

K925550 · CDS

Chemistry · 168d

Cleared Apr 20, 1993

HI CHEM GLUCOSE REAGENT KIT, PRODUCT NO. 88807

K925551 · CGA

Chemistry · 168d

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Hichem Diagnostics - FDA 510(k) Cleared Devices

FDA 510(k) Regulatory Record - Hichem Diagnostics

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