Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

41 results for "Hichem Diagnostics"
1–24 of 41
Search insights Median review: 50d Cleared: 100% Top manufacturer: Hichem Diagnostics Lead specialty: Chemistry
Cleared Jul 29, 1998
HICHEM CALCIUM REAGENT KIT
K981794 · CJY
Hichem Diagnostics
Chemistry · 69d
Cleared Sep 23, 1996
HICHEM ALP/AMP REAGENT KIT
K963383 · CKF
Hichem Diagnostics
Chemistry · 27d
Cleared Sep 06, 1995
HICHEM ISE STANDARDS KIT 70011
K953863 · JIX
Hichem Diagnostics
Chemistry · 20d
Cleared Sep 06, 1995
HICHEM ISEKCI SOLUTION KIT 70010
K953862 · CGZ
Hichem Diagnostics
Chemistry · 20d
Cleared Sep 06, 1995
HICHEM ISE INTDERNAL REFERENCE KIT 70009
K953861 · CGZ
Hichem Diagnostics
Chemistry · 20d
Cleared Sep 06, 1995
HICHEM ISE DILUENT KIT 70008
K953860 · CGZ
Hichem Diagnostics
Chemistry · 20d
Cleared Aug 02, 1995
HICHEM AST REAGENT KIT
K951751 · CIT
Hichem Diagnostics
Chemistry · 107d
Cleared May 02, 1995
HICHEM Y-GT REAGENT KIT
K946192 · JQB
Hichem Diagnostics
Chemistry · 133d
Cleared Feb 23, 1995
HICHEM LDH/L REAGENT KIT
K946022 · CFJ
Hichem Diagnostics
Chemistry · 73d
Cleared Aug 02, 1994
HI CHEM AQUEOUS GLUCOSE CONTROL, LOW, MED, HIGH
K941433 · JJX
Hichem Diagnostics
Chemistry · 131d
Cleared Apr 20, 1993
HI CHEM ELECTROLYTE BUFFER
K925612 · JGS
Hichem Diagnostics
Chemistry · 166d
Cleared Apr 20, 1993
HI CHEM GLUCOSE REAGENT KIT, PRODUCT NO. 88807
K925551 · CGA
Hichem Diagnostics
Chemistry · 168d
Cleared Apr 20, 1993
HI CHEM BUN REAGENT KIT,PRODUCT NUMBER 88806
K925550 · CDS
Hichem Diagnostics
Chemistry · 168d
Cleared Feb 23, 1993
HI CHEM ELECTROLYTE REFERENCE REAGENT
K925611 · JGS
Hichem Diagnostics
Chemistry · 110d
Cleared Feb 12, 1993
HI CHEM CO2 ALKALINE BUFFER REAGENT KIT,PROD#88813
K925553 · JFL
Hichem Diagnostics
Chemistry · 101d
Cleared Feb 12, 1993
HI CHEM CO2 ACID REAGENT KIT,PRODUCT NUMBER 88812
K925552 · JFL
Hichem Diagnostics
Chemistry · 101d
Cleared Sep 25, 1991
HI CHEM LOW/MID/HIGH AQUEOUS GLUCOSE CONTROL
K913792 · JJX
Hichem Diagnostics
Chemistry · 33d
Cleared May 15, 1991
HI CHEM AQUEOUS MULTIANALYTE LINE STAND, MODIFIED
K911803 · JJY
Hichem Diagnostics
Chemistry · 22d
Cleared Oct 26, 1990
URIC ACID/IRON/MAGNESIUM LINEARITY STANDARDS
K904099 · JJY
Hichem Diagnostics
Chemistry · 50d
Cleared Oct 12, 1990
HI CHEM BILIRUBIN LINEARITY SET (PRODUCT #88237)
K904293 · JJY
Hichem Diagnostics
Chemistry · 23d
Cleared Sep 27, 1990
HI CHEM PROTEIN/LIPIDS LINEARITY
K903888 · JIX
Hichem Diagnostics
Chemistry · 36d
Cleared Jun 28, 1990
HI CHEM ENZYME LINEARITY STANDARDS (PROD. 88235)
K902321 · JJT
Hichem Diagnostics
Chemistry · 36d
Cleared Jun 12, 1990
HI CHEM ISE REAGENTS (PRODUCTS #88960 AND #88964)
K902155 · JIM
Hichem Diagnostics
Chemistry · 28d
Cleared Apr 19, 1990
MULTICONSTITUENT SERUM RANGE LINEARITY #88234
K901115 · JJY
Hichem Diagnostics
Chemistry · 41d