American Monitor Corp.
Mchenry, IL, US
American Monitor Corp. appears in FDA device records in Mchenry, IL. FDA records list 73 510(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
- 73
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
Showing 50 of 73FDA records hold 73 510(k) clearances for American Monitor Corp. between 1977 and 1990. The busiest year on record is 1984, with 10. The most recent is 1990, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1977 | 6 |
| 1978 | 4 |
| 1979 | 4 |
| 1980 | 7 |
| 1981 | 5 |
| 1982 | 6 |
| 1983 | 6 |
| 1984 | 10 |
| 1985 | 4 |
| 1986 | 3 |
| 1987 | 6 |
| 1988 | 2 |
| 1989 | 8 |
| 1990 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K896000 | ASPARTATE AMINOTRANFERASE (AST) | CIT | Substantially Equivalent | |
| K895999 | PHOSPHORUS | CEO | Substantially Equivalent | |
| K896001 | ALANINE AMINOTRANSFERASE (ALT) | CKA | Substantially Equivalent | |
| K895423 | ACCESS CHEMISTRY ANALYZER | JJE | Substantially Equivalent | |
| K893137 | EXCEL (TM) CHEMISTRY ANALYZER | JJE | Substantially Equivalent | |
| K892331 | ENZYMATIC UREA NITROGEN REAGENT SET | CDQ | Substantially Equivalent | |
| K893479 | CHOLESTEROL REAGENT SET | CHH | Substantially Equivalent | |
| K892002 | NEOCHROME(R) III GLUCOSE | CGA | Substantially Equivalent | |
| K890312 | GAMMA-GLUTAMYLTRANSFERASE | JQB | Substantially Equivalent | |
| K890034 | PHOTOMETRIC METHOD, IRON (NON-HEME) (75JIY) | JIY | Substantially Equivalent | |
| K883504 | DURAZYME(R) CPK | CGS | Substantially Equivalent | |
| K882497 | ENZYMATIC CO2 REAGENT SET | KHS | Substantially Equivalent | |
| K873074 | SODIUM AND POTASSIUM BY ION SELECTIVE | JGS | Substantially Equivalent | |
| K872073 | BIO-INTERFERENCE BLANKING MATERIAL, AM CAT. #2052 | JIT | Substantially Equivalent | |
| K872181 | ETHANOL CALIBRATOR | DLJ | Substantially Equivalent | |
| K872180 | KINETIC 610 ETHANOL | DML | Substantially Equivalent | |
| K871301 | ENZYMATIC TRIGLYCERIDES GPO-TRINDER METHOD | CDT | Substantially Equivalent | |
| K870277 | MONITORX LASERX THEOPHYLLINE REAGENT SET | LGS | Substantially Equivalent | |
| K862963 | THERAPEUTIC DRUG MONITORING CONTROL SET | JJY | Substantially Equivalent | |
| K862964 | ANTIASTHMATIC CALIBRATORS | DLJ | Substantially Equivalent | |
| K854789 | RANGE-CHEK | JJY | Substantially Equivalent | |
| K854553 | TOTAL PROTEIN | CEK | Substantially Equivalent | |
| K854366 | ENZYMATIC TRIGLYCERIDES GPO-GRINDER METHOD | CDT | Substantially Equivalent | |
| K852350 | HDL CHOLESTEROL PRETREATMENT | LBR | Substantially Equivalent | |
| K852292 | DURAZYME UREA NITROGEN | CDQ | Substantially Equivalent | |
| K843610 | PERSPECTIVE CHEMICAL ANALYZER | JJE | Substantially Equivalent | |
| K843611 | QUALIFY I & II AMER. MONITOR 2009 & 2010 | JJY | Substantially Equivalent | |
| K843008 | ION SELECTIVE ELECTRODES & REAGENT SYS | CEM | Substantially Equivalent | |
| K840368 | DURAZYME CHOLESTEROL | CHH | Substantially Equivalent | |
| K840006 | KINETIC LDH, A< BLUE 610 METHOD | CFJ | Substantially Equivalent | |
| K834251 | HDL CHOLESTEROL PRETREATMENT | LBR | Substantially Equivalent | |
| K834248 | PARALLEL FLAME PHOTOMETER & SODIUM | JGT | Substantially Equivalent | |
| K834033 | KINETIC ALKALINE PHOSPHATASE | CJE | Substantially Equivalent | |
| K833781 | DURAZYME CPK | CGS | Substantially Equivalent | |
| K833009 | OMNI-FAL I & II | JJY | Substantially Equivalent | |
| K833724 | ENZYMATIC CO2 | CIL | Substantially Equivalent | |
| K831202 | SERUM UIBC-PTF-600 METHOD | JMO | Substantially Equivalent | |
| K831201 | SERUM IRON-PTF-600 | JIY | Substantially Equivalent | |
| K830616 | ACTIVATED URIC ACID | CHD | Substantially Equivalent | |
| K830447 | KINETIC CREATININE | CGX | Substantially Equivalent | |
| K823687 | BIO INTERFERENCE BLANKING MATERIAL | JJX | Substantially Equivalent | |
| K822079 | ENZYMATIC CO2 | KHS | Substantially Equivalent | |
| K821905 | BIURET (COLORIMETRIC) TOTAL PROTEIN | CEK | Substantially Equivalent | |
| K821452 | DURAZYME CPK | Substantially Equivalent | ||
| K820832 | PHOSPHORUS IL | CED | Substantially Equivalent | |
| K820473 | ENZYMATIC CHOLESTEROL REAGENT SYSTEM | CHH | Substantially Equivalent | |
| K820235 | TPTZ CHLORIDE | CHJ | Substantially Equivalent | |
| K813215 | Y-GLUTAMYLTRANSFERASE | Substantially Equivalent | ||
| K813076 | PHOSPHOTUNGSTATE REDUCTION, URIC ACID | CDH | Substantially Equivalent | |
| K810434 | GAMMA-GT REAGENT SYSTEM | JQB | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- CED5-Amp-Phosphate Release (Colorimetric Test), 5'-Nucleotidase
- DLIAcetylcholine Chloride, Specific Reagent For Pseudo Cholinesterase
- CHDAcid, Ferric Ion-Sulfuric, Cholesterol
- CDHAcid, Uric, Phosphotungstate Reduction
- KNKAcid, Uric, Uricase (Colorimetric)
- CGXAlkaline Picrate, Colorimetry, Creatinine
- JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use
- CEKBiuret (Colorimetric), Total Protein
- JITCalibrator, Secondary
- DLJCalibrators, Drug Specific
- CILCresol Red Colorimetry, Carbon-Dioxide
- CIGDiazo Colorimetry, Bilirubin
- CEMElectrode, Ion Specific, Potassium
- JGSElectrode, Ion Specific, Sodium
- CHHEnzymatic Esterase--Oxidase, Cholesterol
- KHSEnzymatic, Carbon-Dioxide
- JMOFerrozine (Colorimetric) Iron Binding Capacity
- JIHFlame Photometry, Lithium
- JGTFlame Photometry, Sodium
- LGSFluorescence Polarization Immunoassay, Theophylline
- CGAGlucose Oxidase, Glucose
- CFRHexokinase, Glucose
- JQBKinetic Method, Gamma-Glutamyl Transpeptidase
- LBRLdl & Vldl Precipitation, Hdl
- CDTLipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
- CHJMercuric Thiocyanate, Colorimetry, Chloride
- JJYMulti-Analyte Controls, All Kinds (Assayed)
- CGSNad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
- CFJNad Reduction/Nadh Oxidation, Lactate Dehydrogenase
- DMLNad-Nadh, Specific Reagent For Alcohol Enzyme Method
- CKANadh Oxidation/Nad Reduction, Alt/Sgpt
- CITNadh Oxidation/Nad Reduction, Ast/Sgot
- CJENitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
- JGZO-Phthalaldehyde, Urea Nitrogen
- CEOPhosphomolybdate (Colorimetric), Inorganic Phosphorus
- JIYPhotometric Method, Iron (Non-Heme)
- JGJPhotometric Method, Magnesium
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
- JTXTransport Systems, Anaerobic
- CDQUrease And Glutamic Dehydrogenase, Urea Nitrogen
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