Hichem Diagnostics
Brea, CA, US
Hichem Diagnostics appears in FDA device records in Brea, CA. FDA records list 41 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 41
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 41 510(k) clearances for Hichem Diagnostics between 1988 and 1998. The busiest year on record is 1989, with 11. The most recent is 1998, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1988 | 6 |
| 1989 | 11 |
| 1990 | 6 |
| 1991 | 2 |
| 1993 | 6 |
| 1994 | 1 |
| 1995 | 7 |
| 1996 | 1 |
| 1998 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K981794 | HICHEM CALCIUM REAGENT KIT | CJY | Substantially Equivalent | |
| K963383 | HICHEM ALP/AMP REAGENT KIT | CKF | Substantially Equivalent | |
| K953863 | HICHEM ISE STANDARDS KIT 70011 | JIX | Substantially Equivalent | |
| K953862 | HICHEM ISEKCI SOLUTION KIT 70010 | CGZ | Substantially Equivalent | |
| K953861 | HICHEM ISE INTDERNAL REFERENCE KIT 70009 | CGZ | Substantially Equivalent | |
| K953860 | HICHEM ISE DILUENT KIT 70008 | CGZ | Substantially Equivalent | |
| K951751 | HICHEM AST REAGENT KIT | CIT | Substantially Equivalent | |
| K946192 | HICHEM Y-GT REAGENT KIT | JQB | Substantially Equivalent | |
| K946022 | HICHEM LDH/L REAGENT KIT | CFJ | Substantially Equivalent | |
| K941433 | HI CHEM AQUEOUS GLUCOSE CONTROL, LOW, MED, HIGH | JJX | Substantially Equivalent | |
| K925612 | HI CHEM ELECTROLYTE BUFFER | JGS | Substantially Equivalent | |
| K925551 | HI CHEM GLUCOSE REAGENT KIT, PRODUCT NO. 88807 | CGA | Substantially Equivalent | |
| K925550 | HI CHEM BUN REAGENT KIT,PRODUCT NUMBER 88806 | CDS | Substantially Equivalent | |
| K925611 | HI CHEM ELECTROLYTE REFERENCE REAGENT | JGS | Substantially Equivalent | |
| K925553 | HI CHEM CO2 ALKALINE BUFFER REAGENT KIT,PROD#88813 | JFL | Substantially Equivalent | |
| K925552 | HI CHEM CO2 ACID REAGENT KIT,PRODUCT NUMBER 88812 | JFL | Substantially Equivalent | |
| K913792 | HI CHEM LOW/MID/HIGH AQUEOUS GLUCOSE CONTROL | JJX | Substantially Equivalent | |
| K911803 | HI CHEM AQUEOUS MULTIANALYTE LINE STAND, MODIFIED | JJY | Substantially Equivalent | |
| K904099 | URIC ACID/IRON/MAGNESIUM LINEARITY STANDARDS | JJY | Substantially Equivalent | |
| K904293 | HI CHEM BILIRUBIN LINEARITY SET (PRODUCT #88237) | JJY | Substantially Equivalent | |
| K903888 | HI CHEM PROTEIN/LIPIDS LINEARITY | JIX | Substantially Equivalent | |
| K902321 | HI CHEM ENZYME LINEARITY STANDARDS (PROD. 88235) | JJT | Substantially Equivalent | |
| K902155 | HI CHEM ISE REAGENTS (PRODUCTS #88960 AND #88964) | JIM | Substantially Equivalent | |
| K901115 | MULTICONSTITUENT SERUM RANGE LINEARITY #88234 | JJY | Substantially Equivalent | |
| K895555 | MODIFIED HI CHEM AMYLASE REAGENT (PRODUCT #88129) | CJA | Substantially Equivalent | |
| K895585 | HI CHEM TRIGLYCERIDES CALIBRATOR E (88185) | JIS | Substantially Equivalent | |
| K895135 | HI CHEM CALIBRATOR A+ | JIX | Substantially Equivalent | |
| K890671 | HI CHEM CREATININE REAGENT (PRODUCT #88809) | CGX | Substantially Equivalent | |
| K890773 | HI CHEM INORGANIC PHOSPHORUS REAGENT KIT #88196 | CEO | Substantially Equivalent | |
| K890990 | EXTEND INTENDED USE FOR ENZYME RINSE CONCENTRATE | CHH | Substantially Equivalent | |
| K890584 | HI CHEM CALCIUM REAGENT #88808 | CJY | Substantially Equivalent | |
| K890583 | HI CHEM CALIBRATION STANDARDS LEVELS 1 AND 2 | JIX | Substantially Equivalent | |
| K890578 | HI CHEM WASH CONCENTRATE REAGENT #88805 | JQW | Substantially Equivalent | |
| K890184 | MODIFIED INTENDED USE OF CLEANING REAGENT KIT | JJE | Substantially Equivalent | |
| K890183 | MODIFIED INTENDED USE ON CLEANING NEUTRALIZER SOL. | JJE | Substantially Equivalent | |
| K883844 | HI CHEM KINETIC CHOLESTEROL REAGENT #88218 | CHH | Substantially Equivalent | |
| K883405 | TRIGLYCERIDES REAGENT (PRODUCT #88218) | CDT | Substantially Equivalent | |
| K883404 | URIC ACID REAGENT (PRODUCT #88219) | KNK | Substantially Equivalent | |
| K881438 | UREA/GLUCOSE/CREATININE SERUM RANGE LINEARITY STAN | JJY | Substantially Equivalent | |
| K881437 | CHLORIDE/TOTAL CO2 SERUM RANGE LINEARITY STANDARDS | JJY | Substantially Equivalent | |
| K881436 | SODIUM/POTASSIUM SERUM RANGE LINEARITY STANDARDS | JJY | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KNKAcid, Uric, Uricase (Colorimetric)
- CGXAlkaline Picrate, Colorimetry, Creatinine
- CJAAmyloclastic, Amylase
- JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use
- CJYAzo Dye, Calcium
- JIXCalibrator, Multi-Analyte Mixture
- JISCalibrator, Primary
- JGSElectrode, Ion Specific, Sodium
- CDSElectrode, Ion Specific, Urea Nitrogen
- CGZElectrode, Ion-Specific, Chloride
- CHHEnzymatic Esterase--Oxidase, Cholesterol
- JJTEnzyme Controls (Assayed And Unassayed)
- CGAGlucose Oxidase, Glucose
- JQBKinetic Method, Gamma-Glutamyl Transpeptidase
- CDTLipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
- JIMMethod, Metallic Reduction, Glucose (Urinary, Non-Quantitative)
- JJYMulti-Analyte Controls, All Kinds (Assayed)
- CFJNad Reduction/Nadh Oxidation, Lactate Dehydrogenase
- CITNadh Oxidation/Nad Reduction, Ast/Sgot
- JFLPh Rate Measurement, Carbon-Dioxide
- CKFPhenylphosphate, Alkaline Phosphatase Or Isoenzymes
- CEOPhosphomolybdate (Colorimetric), Inorganic Phosphorus
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
- JQWStation, Pipetting And Diluting, For Clinical Use
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain