Hichem Diagnostics
Hichem Diagnostics appears in FDA public data with 0 recalls, 41 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on July 29, 1998.
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 41
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K981794 | HICHEM CALCIUM REAGENT KIT | July 29, 1998 |
| K963383 | HICHEM ALP/AMP REAGENT KIT | September 23, 1996 |
| K953863 | HICHEM ISE STANDARDS KIT 70011 | September 6, 1995 |
| K953862 | HICHEM ISEKCI SOLUTION KIT 70010 | September 6, 1995 |
| K953860 | HICHEM ISE DILUENT KIT 70008 | September 6, 1995 |
| K953861 | HICHEM ISE INTDERNAL REFERENCE KIT 70009 | September 6, 1995 |
| K951751 | HICHEM AST REAGENT KIT | August 2, 1995 |
| K946192 | HICHEM Y-GT REAGENT KIT | May 2, 1995 |
| K946022 | HICHEM LDH/L REAGENT KIT | February 23, 1995 |
| K941433 | HI CHEM AQUEOUS GLUCOSE CONTROL, LOW, MED, HIGH | August 2, 1994 |
| K925550 | HI CHEM BUN REAGENT KIT,PRODUCT NUMBER 88806 | April 20, 1993 |
| K925551 | HI CHEM GLUCOSE REAGENT KIT, PRODUCT NO. 88807 | April 20, 1993 |
| K925612 | HI CHEM ELECTROLYTE BUFFER | April 20, 1993 |
| K925611 | HI CHEM ELECTROLYTE REFERENCE REAGENT | February 23, 1993 |
| K925553 | HI CHEM CO2 ALKALINE BUFFER REAGENT KIT,PROD#88813 | February 12, 1993 |
| K925552 | HI CHEM CO2 ACID REAGENT KIT,PRODUCT NUMBER 88812 | February 12, 1993 |
| K913792 | HI CHEM LOW/MID/HIGH AQUEOUS GLUCOSE CONTROL | September 25, 1991 |
| K911803 | HI CHEM AQUEOUS MULTIANALYTE LINE STAND, MODIFIED | May 15, 1991 |
| K904099 | URIC ACID/IRON/MAGNESIUM LINEARITY STANDARDS | October 26, 1990 |
| K904293 | HI CHEM BILIRUBIN LINEARITY SET (PRODUCT #88237) | October 12, 1990 |