Company ยท US
Hi Chem, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1977 to 1996. Name variants (Inc, Corp, punctuation) are merged.
52510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CEM | Electrode, Ion Specific, Potassium | 3 |
| CGA | Glucose Oxidase, Glucose | 3 |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 3 |
| CKA | Nadh Oxidation/Nad Reduction, Alt/Sgpt | 3 |
| JGS | Electrode, Ion Specific, Sodium | 3 |
| JIS | Calibrator, Primary | 3 |
| JIX | Calibrator, Multi-Analyte Mixture | 3 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 3 |
| CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | 2 |
| CIG | Diazo Colorimetry, Bilirubin | 2 |
| JFL | Ph Rate Measurement, Carbon-Dioxide | 2 |
| JFS | Coulometric, Chloride | 2 |
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 2 |
| JJF | Analyzer, Chemistry, Micro, For Clinical Use | 2 |
| CDS | Electrode, Ion Specific, Urea Nitrogen | 1 |
| CEK | Biuret (Colorimetric), Total Protein | 1 |
| CFR | Hexokinase, Glucose | 1 |
| CGS | Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes | 1 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 1 |
| CIC | Cresolphthalein Complexone, Calcium | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 4, 1996 | K960084 | HICHEM GLUCOSE/HK REAGENT KIT Hi Chem, Inc. | CFR |
| May 15, 1995 | K951818 | HICHEM ALT REAGENT KIT Hi Chem, Inc. | CKA |
| Oct 4, 1994 | K943684 | HICHEM ENZYME VERIFIER KIT Hi Chem, Inc. | JJT |
| May 13, 1994 | K941764 | HICHEM CALCIUM REAGENT FOR THE SYNCHRON CX3 PROD. NO. 88808 Hi Chem, Inc. | CJY |
| Jul 17, 1990 | K902673 | HI CHEM TOTAL PROTEIN/ALBUMIN SERUM RANGE LIN STND Hi Chem, Inc. | JJY |
| Oct 24, 1986 | K863617 | ION 2/4 FLOW CELL CLEANER (PRODUCT #88656) Hi Chem, Inc. | JGS |
| Jun 13, 1986 | K862027 | LDP REAGENT CARTRIDGE (NO. 88216) Hi Chem, Inc. | CFJ |
| Jun 5, 1986 | K861893 | GGT REAGENT CARTRIDGE (PRODUCT NO. 88204) Hi Chem, Inc. | JXL |
| May 29, 1986 | K861879 | CK REAGENT CARTRIDGE (PRODUCT NO. 88213) Hi Chem, Inc. | CGS |
| Apr 28, 1986 | K861419 | HI CHEM DIAGNOSTICS LDL REAGENT CARTRIDGE Hi Chem, Inc. | CFJ |
| Apr 28, 1986 | K861284 | AP REAGENT CARTRIDGE Hi Chem, Inc. | CJE |
| Apr 28, 1986 | K861283 | AST REAGENT CARTRIDGE Hi Chem, Inc. | CIT |
| Apr 28, 1986 | K861231 | ALT REAGENT CARTRIDGE (PRODUCT NO. 88210) Hi Chem, Inc. | CKA |
| Jan 22, 1986 | K855196 | CLEANING REAGENT KIT PRODUCT NO 88194 Hi Chem, Inc. | JJE |
| Aug 29, 1985 | K852867 | HI-CHEM DIAGNOSTICS ENZYME RINSE CONCENTRATE Hi Chem, Inc. | CKA |
| Aug 6, 1985 | K853003 | HI CHEM DIAGNOSTICS CLEANING NEUTRALIZER SOL#88193 Hi Chem, Inc. | JJE |
| Apr 29, 1985 | K851350 | ION 2 REAGENT KI Hi Chem, Inc. | CEM |
| Apr 1, 1985 | K850405 | CALIBRATOR B 88133 Hi Chem, Inc. | JIX |
| Aug 16, 1984 | K842450 | HICHEM ION 2/4 URINE RANGE CALIBRATOR Hi Chem, Inc. | JIS |
| Aug 16, 1984 | K842449 | HICHEM ION 2/4 SERUM RANGE CALIBRATOR Hi Chem, Inc. | JIS |
| Jun 22, 1984 | K842025 | ION 4 SODIUM/POTASSIUM/CHLORIDE/TOTAL Hi Chem, Inc. | JGS |
| May 16, 1984 | K841572 | DIRECT BILIRUBIN REAGENT Hi Chem, Inc. | CIG |
| Nov 25, 1983 | K833159 | POTASSIUM ELECTRODE TIP ASSAMBLY-K- Hi Chem, Inc. | CEM |
| Jun 30, 1983 | K831295 | AMYLASE REAGENT #88129 Hi Chem, Inc. | KHM |
| Apr 6, 1983 | K830714 | TOTAL BILIRUBIN REAGENT Hi Chem, Inc. | CIG |
| Feb 7, 1983 | K830137 | CALIBRATOR A Hi Chem, Inc. | JIS |
| May 21, 1982 | K821225 | ALBUMIN REAGENT Hi Chem, Inc. | CIX |
| Jan 28, 1982 | K820090 | ASTRA-T CALCIUM REAGENT Hi Chem, Inc. | CIC |
| Dec 31, 1981 | K813536 | ASTRA TOTAL PROTEIN REAGENT Hi Chem, Inc. | CEK |
| Dec 22, 1981 | K813370 | ELECTROLYTE GEL Hi Chem, Inc. | CGA |
| Nov 5, 1981 | K812700 | URICAR Hi Chem, Inc. | KNK |
| Oct 31, 1980 | K802264 | WASH SOLUTION KIT, #88102 Hi Chem, Inc. | JJF |
| Oct 23, 1980 | K802392 | ASTRA PRINTER PAPER #88112-CHLORIDE SILV Hi Chem, Inc. | JJF |
| Oct 23, 1980 | K801892 | KLINAR REAGENT PAK, #36010 Hi Chem, Inc. | JGT |
| Apr 10, 1980 | K800616 | BUN REAGENT KIT #88108 Hi Chem, Inc. | CDS |
| Sep 27, 1979 | K791365 | FAST FLOW #60310 Hi Chem, Inc. | LCP |
| Sep 24, 1979 | K791696 | CONTRO II Hi Chem, Inc. | JJY |
| Sep 24, 1979 | K791695 | CONTRO I Hi Chem, Inc. | JJY |
| Sep 17, 1979 | K791694 | CALIBRATOR II Hi Chem, Inc. | JIX |
| Sep 17, 1979 | K791693 | CALIBRATOR I Hi Chem, Inc. | JIX |
| Sep 17, 1979 | K791692 | SODIUM/POTASSIUM BUFFER SOLUTION Hi Chem, Inc. | CEM |
| Sep 17, 1979 | K791691 | SODIUM/POTASSIUM CONDITIONING SOLUTION Hi Chem, Inc. | JGS |
| Sep 17, 1979 | K791690 | CHOLORDE REAGENT Hi Chem, Inc. | JFS |
| Sep 17, 1979 | K791689 | PICRIC SOLUTION Hi Chem, Inc. | CGX |
| Sep 17, 1979 | K791688 | ALKALINE BUFFER Hi Chem, Inc. | CGX |
| Sep 17, 1979 | K791687 | CO2 REFERENCE REAGENT Hi Chem, Inc. | JFL |
| Sep 17, 1979 | K791686 | CO2 CUP REAGENT Hi Chem, Inc. | JFL |
| Sep 17, 1979 | K791685 | GLUCOSE REAGENT Hi Chem, Inc. | CGA |
| Jan 17, 1979 | K782094 | HILAR Hi Chem, Inc. | CGX |
| Aug 10, 1978 | K781132 | CHEMLAR Hi Chem, Inc. | JFS |
Newest 50 of 52.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||