Company ยท US
Hichem Diagnostics
FDA 510(k) clearances and medical device recalls filed under this name, 1988 to 1998. Name variants (Inc, Corp, punctuation) are merged.
41510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 7 |
| JIX | Calibrator, Multi-Analyte Mixture | 4 |
| CGZ | Electrode, Ion-Specific, Chloride | 3 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 2 |
| CJY | Azo Dye, Calcium | 2 |
| JFL | Ph Rate Measurement, Carbon-Dioxide | 2 |
| JGS | Electrode, Ion Specific, Sodium | 2 |
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 2 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 2 |
| CDS | Electrode, Ion Specific, Urea Nitrogen | 1 |
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 1 |
| CEO | Phosphomolybdate (Colorimetric), Inorganic Phosphorus | 1 |
| CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | 1 |
| CGA | Glucose Oxidase, Glucose | 1 |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 1 |
| CIT | Nadh Oxidation/Nad Reduction, Ast/Sgot | 1 |
| CJA | Amyloclastic, Amylase | 1 |
| CKF | Phenylphosphate, Alkaline Phosphatase Or Isoenzymes | 1 |
| JIM | Method, Metallic Reduction, Glucose (Urinary, Non-Quantitative) | 1 |
| JIS | Calibrator, Primary | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 29, 1998 | K981794 | HICHEM CALCIUM REAGENT KIT Hichem Diagnostics | CJY |
| Sep 23, 1996 | K963383 | HICHEM ALP/AMP REAGENT KIT Hichem Diagnostics | CKF |
| Sep 6, 1995 | K953863 | HICHEM ISE STANDARDS KIT 70011 Hichem Diagnostics | JIX |
| Sep 6, 1995 | K953862 | HICHEM ISEKCI SOLUTION KIT 70010 Hichem Diagnostics | CGZ |
| Sep 6, 1995 | K953861 | HICHEM ISE INTDERNAL REFERENCE KIT 70009 Hichem Diagnostics | CGZ |
| Sep 6, 1995 | K953860 | HICHEM ISE DILUENT KIT 70008 Hichem Diagnostics | CGZ |
| Aug 2, 1995 | K951751 | HICHEM AST REAGENT KIT Hichem Diagnostics | CIT |
| May 2, 1995 | K946192 | HICHEM Y-GT REAGENT KIT Hichem Diagnostics | JQB |
| Feb 23, 1995 | K946022 | HICHEM LDH/L REAGENT KIT Hichem Diagnostics | CFJ |
| Aug 2, 1994 | K941433 | HI CHEM AQUEOUS GLUCOSE CONTROL, LOW, MED, HIGH Hichem Diagnostics | JJX |
| Apr 20, 1993 | K925612 | HI CHEM ELECTROLYTE BUFFER Hichem Diagnostics | JGS |
| Apr 20, 1993 | K925551 | HI CHEM GLUCOSE REAGENT KIT, PRODUCT NO. 88807 Hichem Diagnostics | CGA |
| Apr 20, 1993 | K925550 | HI CHEM BUN REAGENT KIT,PRODUCT NUMBER 88806 Hichem Diagnostics | CDS |
| Feb 23, 1993 | K925611 | HI CHEM ELECTROLYTE REFERENCE REAGENT Hichem Diagnostics | JGS |
| Feb 12, 1993 | K925553 | HI CHEM CO2 ALKALINE BUFFER REAGENT KIT,PROD#88813 Hichem Diagnostics | JFL |
| Feb 12, 1993 | K925552 | HI CHEM CO2 ACID REAGENT KIT,PRODUCT NUMBER 88812 Hichem Diagnostics | JFL |
| Sep 25, 1991 | K913792 | HI CHEM LOW/MID/HIGH AQUEOUS GLUCOSE CONTROL Hichem Diagnostics | JJX |
| May 15, 1991 | K911803 | HI CHEM AQUEOUS MULTIANALYTE LINE STAND, MODIFIED Hichem Diagnostics | JJY |
| Oct 26, 1990 | K904099 | URIC ACID/IRON/MAGNESIUM LINEARITY STANDARDS Hichem Diagnostics | JJY |
| Oct 12, 1990 | K904293 | HI CHEM BILIRUBIN LINEARITY SET (PRODUCT #88237) Hichem Diagnostics | JJY |
| Sep 27, 1990 | K903888 | HI CHEM PROTEIN/LIPIDS LINEARITY Hichem Diagnostics | JIX |
| Jun 28, 1990 | K902321 | HI CHEM ENZYME LINEARITY STANDARDS (PROD. 88235) Hichem Diagnostics | JJT |
| Jun 12, 1990 | K902155 | HI CHEM ISE REAGENTS (PRODUCTS #88960 AND #88964) Hichem Diagnostics | JIM |
| Apr 19, 1990 | K901115 | MULTICONSTITUENT SERUM RANGE LINEARITY #88234 Hichem Diagnostics | JJY |
| Dec 22, 1989 | K895555 | MODIFIED HI CHEM AMYLASE REAGENT (PRODUCT #88129) Hichem Diagnostics | CJA |
| Nov 13, 1989 | K895585 | HI CHEM TRIGLYCERIDES CALIBRATOR E (88185) Hichem Diagnostics | JIS |
| Oct 23, 1989 | K895135 | HI CHEM CALIBRATOR A+ Hichem Diagnostics | JIX |
| May 9, 1989 | K890671 | HI CHEM CREATININE REAGENT (PRODUCT #88809) Hichem Diagnostics | CGX |
| Apr 18, 1989 | K890773 | HI CHEM INORGANIC PHOSPHORUS REAGENT KIT #88196 Hichem Diagnostics | CEO |
| Apr 10, 1989 | K890990 | EXTEND INTENDED USE FOR ENZYME RINSE CONCENTRATE Hichem Diagnostics | CHH |
| Apr 10, 1989 | K890584 | HI CHEM CALCIUM REAGENT #88808 Hichem Diagnostics | CJY |
| Mar 13, 1989 | K890583 | HI CHEM CALIBRATION STANDARDS LEVELS 1 AND 2 Hichem Diagnostics | JIX |
| Mar 10, 1989 | K890578 | HI CHEM WASH CONCENTRATE REAGENT #88805 Hichem Diagnostics | JQW |
| Feb 7, 1989 | K890184 | MODIFIED INTENDED USE OF CLEANING REAGENT KIT Hichem Diagnostics | JJE |
| Feb 7, 1989 | K890183 | MODIFIED INTENDED USE ON CLEANING NEUTRALIZER SOL. Hichem Diagnostics | JJE |
| Oct 31, 1988 | K883844 | HI CHEM KINETIC CHOLESTEROL REAGENT #88218 Hichem Diagnostics | CHH |
| Sep 13, 1988 | K883405 | TRIGLYCERIDES REAGENT (PRODUCT #88218) Hichem Diagnostics | CDT |
| Sep 13, 1988 | K883404 | URIC ACID REAGENT (PRODUCT #88219) Hichem Diagnostics | KNK |
| Jul 6, 1988 | K881438 | UREA/GLUCOSE/CREATININE SERUM RANGE LINEARITY STAN Hichem Diagnostics | JJY |
| Jul 6, 1988 | K881437 | CHLORIDE/TOTAL CO2 SERUM RANGE LINEARITY STANDARDS Hichem Diagnostics | JJY |
| Jun 2, 1988 | K881436 | SODIUM/POTASSIUM SERUM RANGE LINEARITY STANDARDS Hichem Diagnostics | JJY |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||