Hi Chem, Inc.
Mchenry, IL, US
Hi Chem, Inc. appears in FDA device records in Mchenry, IL. FDA records list 52 510(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
- 52
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
Showing 50 of 52FDA records hold 52 510(k) clearances for Hi Chem, Inc. between 1977 and 1996. The busiest year on record is 1979, with 14. The most recent is 1996, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1977 | 2 |
| 1978 | 1 |
| 1979 | 14 |
| 1980 | 4 |
| 1981 | 3 |
| 1982 | 2 |
| 1983 | 4 |
| 1984 | 4 |
| 1985 | 4 |
| 1986 | 9 |
| 1990 | 1 |
| 1994 | 2 |
| 1995 | 1 |
| 1996 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K960084 | HICHEM GLUCOSE/HK REAGENT KIT | CFR | Substantially Equivalent | |
| K951818 | HICHEM ALT REAGENT KIT | CKA | Substantially Equivalent | |
| K943684 | HICHEM ENZYME VERIFIER KIT | JJT | Substantially Equivalent | |
| K941764 | HICHEM CALCIUM REAGENT FOR THE SYNCHRON CX3 PROD. NO. 88808 | CJY | Substantially Equivalent | |
| K902673 | HI CHEM TOTAL PROTEIN/ALBUMIN SERUM RANGE LIN STND | JJY | Substantially Equivalent | |
| K863617 | ION 2/4 FLOW CELL CLEANER (PRODUCT #88656) | JGS | Substantially Equivalent | |
| K862027 | LDP REAGENT CARTRIDGE (NO. 88216) | CFJ | Substantially Equivalent | |
| K861893 | GGT REAGENT CARTRIDGE (PRODUCT NO. 88204) | JXL | Substantially Equivalent | |
| K861879 | CK REAGENT CARTRIDGE (PRODUCT NO. 88213) | CGS | Substantially Equivalent | |
| K861419 | HI CHEM DIAGNOSTICS LDL REAGENT CARTRIDGE | CFJ | Substantially Equivalent | |
| K861284 | AP REAGENT CARTRIDGE | CJE | Substantially Equivalent | |
| K861283 | AST REAGENT CARTRIDGE | CIT | Substantially Equivalent | |
| K861231 | ALT REAGENT CARTRIDGE (PRODUCT NO. 88210) | CKA | Substantially Equivalent | |
| K855196 | CLEANING REAGENT KIT PRODUCT NO 88194 | JJE | Substantially Equivalent | |
| K852867 | HI-CHEM DIAGNOSTICS ENZYME RINSE CONCENTRATE | CKA | Substantially Equivalent | |
| K853003 | HI CHEM DIAGNOSTICS CLEANING NEUTRALIZER SOL#88193 | JJE | Substantially Equivalent | |
| K851350 | ION 2 REAGENT KI | CEM | Substantially Equivalent | |
| K850405 | CALIBRATOR B 88133 | JIX | Substantially Equivalent | |
| K842450 | HICHEM ION 2/4 URINE RANGE CALIBRATOR | JIS | Substantially Equivalent | |
| K842449 | HICHEM ION 2/4 SERUM RANGE CALIBRATOR | JIS | Substantially Equivalent | |
| K842025 | ION 4 SODIUM/POTASSIUM/CHLORIDE/TOTAL | JGS | Substantially Equivalent | |
| K841572 | DIRECT BILIRUBIN REAGENT | CIG | Substantially Equivalent | |
| K833159 | POTASSIUM ELECTRODE TIP ASSAMBLY-K- | CEM | Substantially Equivalent | |
| K831295 | AMYLASE REAGENT #88129 | KHM | Substantially Equivalent | |
| K830714 | TOTAL BILIRUBIN REAGENT | CIG | Substantially Equivalent | |
| K830137 | CALIBRATOR A | JIS | Substantially Equivalent | |
| K821225 | ALBUMIN REAGENT | CIX | Substantially Equivalent | |
| K820090 | ASTRA-T CALCIUM REAGENT | CIC | Substantially Equivalent | |
| K813536 | ASTRA TOTAL PROTEIN REAGENT | CEK | Substantially Equivalent | |
| K813370 | ELECTROLYTE GEL | CGA | Substantially Equivalent | |
| K812700 | URICAR | KNK | Substantially Equivalent | |
| K802264 | WASH SOLUTION KIT, #88102 | JJF | Substantially Equivalent | |
| K802392 | ASTRA PRINTER PAPER #88112-CHLORIDE SILV | JJF | Substantially Equivalent | |
| K801892 | KLINAR REAGENT PAK, #36010 | JGT | Substantially Equivalent | |
| K800616 | BUN REAGENT KIT #88108 | CDS | Substantially Equivalent | |
| K791365 | FAST FLOW #60310 | LCP | Substantially Equivalent | |
| K791696 | CONTRO II | JJY | Substantially Equivalent | |
| K791695 | CONTRO I | JJY | Substantially Equivalent | |
| K791694 | CALIBRATOR II | JIX | Substantially Equivalent | |
| K791693 | CALIBRATOR I | JIX | Substantially Equivalent | |
| K791692 | SODIUM/POTASSIUM BUFFER SOLUTION | CEM | Substantially Equivalent | |
| K791691 | SODIUM/POTASSIUM CONDITIONING SOLUTION | JGS | Substantially Equivalent | |
| K791690 | CHOLORDE REAGENT | JFS | Substantially Equivalent | |
| K791689 | PICRIC SOLUTION | CGX | Substantially Equivalent | |
| K791688 | ALKALINE BUFFER | CGX | Substantially Equivalent | |
| K791687 | CO2 REFERENCE REAGENT | JFL | Substantially Equivalent | |
| K791686 | CO2 CUP REAGENT | JFL | Substantially Equivalent | |
| K791685 | GLUCOSE REAGENT | CGA | Substantially Equivalent | |
| K782094 | HILAR | CGX | Substantially Equivalent | |
| K781132 | CHEMLAR | JFS | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KNKAcid, Uric, Uricase (Colorimetric)
- CGXAlkaline Picrate, Colorimetry, Creatinine
- JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use
- JJFAnalyzer, Chemistry, Micro, For Clinical Use
- LCPAssay, Glycosylated Hemoglobin
- CJYAzo Dye, Calcium
- CEKBiuret (Colorimetric), Total Protein
- JXLBlock, Bite
- CIXBromcresol Green Dye-Binding, Albumin
- JIXCalibrator, Multi-Analyte Mixture
- JISCalibrator, Primary
- JFSCoulometric, Chloride
- CICCresolphthalein Complexone, Calcium
- CIGDiazo Colorimetry, Bilirubin
- CEMElectrode, Ion Specific, Potassium
- JGSElectrode, Ion Specific, Sodium
- CDSElectrode, Ion Specific, Urea Nitrogen
- CHHEnzymatic Esterase--Oxidase, Cholesterol
- JJTEnzyme Controls (Assayed And Unassayed)
- JGTFlame Photometry, Sodium
- CGAGlucose Oxidase, Glucose
- CFRHexokinase, Glucose
- JJYMulti-Analyte Controls, All Kinds (Assayed)
- CGSNad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
- CFJNad Reduction/Nadh Oxidation, Lactate Dehydrogenase
- CKANadh Oxidation/Nad Reduction, Alt/Sgpt
- CITNadh Oxidation/Nad Reduction, Ast/Sgot
- KHMNephelometric, Amylase
- CJENitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
- JFLPh Rate Measurement, Carbon-Dioxide
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