Company ยท US
American Monitor Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1977 to 1990. Name variants (Inc, Corp, punctuation) are merged.
73510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 5 |
| CIT | Nadh Oxidation/Nad Reduction, Ast/Sgot | 5 |
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 5 |
| CKA | Nadh Oxidation/Nad Reduction, Alt/Sgpt | 4 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 4 |
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 2 |
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 2 |
| CEK | Biuret (Colorimetric), Total Protein | 2 |
| CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | 2 |
| CGA | Glucose Oxidase, Glucose | 2 |
| CGS | Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes | 2 |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 2 |
| CIL | Cresol Red Colorimetry, Carbon-Dioxide | 2 |
| DLJ | Calibrators, Drug Specific | 2 |
| JIY | Photometric Method, Iron (Non-Heme) | 2 |
| JQB | Kinetic Method, Gamma-Glutamyl Transpeptidase | 2 |
| KHS | Enzymatic, Carbon-Dioxide | 2 |
| LBR | Ldl & Vldl Precipitation, Hdl | 2 |
| CDH | Acid, Uric, Phosphotungstate Reduction | 1 |
| CED | 5-Amp-Phosphate Release (Colorimetric Test), 5'-Nucleotidase | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 11, 1990 | K896000 | ASPARTATE AMINOTRANFERASE (AST) American Monitor Corp. | CIT |
| Jan 11, 1990 | K895999 | PHOSPHORUS American Monitor Corp. | CEO |
| Nov 13, 1989 | K896001 | ALANINE AMINOTRANSFERASE (ALT) American Monitor Corp. | CKA |
| Oct 4, 1989 | K895423 | ACCESS CHEMISTRY ANALYZER American Monitor Corp. | JJE |
| Aug 10, 1989 | K893137 | EXCEL (TM) CHEMISTRY ANALYZER American Monitor Corp. | JJE |
| Jun 20, 1989 | K892331 | ENZYMATIC UREA NITROGEN REAGENT SET American Monitor Corp. | CDQ |
| Jun 19, 1989 | K893479 | CHOLESTEROL REAGENT SET American Monitor Corp. | CHH |
| Jun 12, 1989 | K892002 | NEOCHROME(R) III GLUCOSE American Monitor Corp. | CGA |
| Mar 24, 1989 | K890312 | GAMMA-GLUTAMYLTRANSFERASE American Monitor Corp. | JQB |
| Feb 3, 1989 | K890034 | PHOTOMETRIC METHOD, IRON (NON-HEME) (75JIY) American Monitor Corp. | JIY |
| Sep 13, 1988 | K883504 | DURAZYME(R) CPK American Monitor Corp. | CGS |
| Aug 2, 1988 | K882497 | ENZYMATIC CO2 REAGENT SET American Monitor Corp. | KHS |
| Oct 20, 1987 | K873074 | SODIUM AND POTASSIUM BY ION SELECTIVE American Monitor Corp. | JGS |
| Sep 11, 1987 | K872073 | BIO-INTERFERENCE BLANKING MATERIAL, AM CAT. #2052 American Monitor Corp. | JIT |
| Jul 21, 1987 | K872181 | ETHANOL CALIBRATOR American Monitor Corp. | DLJ |
| Jul 7, 1987 | K872180 | KINETIC 610 ETHANOL American Monitor Corp. | DML |
| Apr 22, 1987 | K871301 | ENZYMATIC TRIGLYCERIDES GPO-TRINDER METHOD American Monitor Corp. | CDT |
| Feb 18, 1987 | K870277 | MONITORX LASERX THEOPHYLLINE REAGENT SET American Monitor Corp. | LGS |
| Sep 15, 1986 | K862963 | THERAPEUTIC DRUG MONITORING CONTROL SET American Monitor Corp. | JJY |
| Aug 19, 1986 | K862964 | ANTIASTHMATIC CALIBRATORS American Monitor Corp. | DLJ |
| Jan 13, 1986 | K854789 | RANGE-CHEK American Monitor Corp. | JJY |
| Nov 25, 1985 | K854553 | TOTAL PROTEIN American Monitor Corp. | CEK |
| Nov 25, 1985 | K854366 | ENZYMATIC TRIGLYCERIDES GPO-GRINDER METHOD American Monitor Corp. | CDT |
| Jul 8, 1985 | K852350 | HDL CHOLESTEROL PRETREATMENT American Monitor Corp. | LBR |
| Jul 8, 1985 | K852292 | DURAZYME UREA NITROGEN American Monitor Corp. | CDQ |
| Oct 5, 1984 | K843610 | PERSPECTIVE CHEMICAL ANALYZER American Monitor Corp. | JJE |
| Sep 28, 1984 | K843611 | QUALIFY I & II AMER. MONITOR 2009 & 2010 American Monitor Corp. | JJY |
| Sep 4, 1984 | K843008 | ION SELECTIVE ELECTRODES & REAGENT SYS American Monitor Corp. | CEM |
| Mar 30, 1984 | K840368 | DURAZYME CHOLESTEROL American Monitor Corp. | CHH |
| Mar 23, 1984 | K840006 | KINETIC LDH, A< BLUE 610 METHOD American Monitor Corp. | CFJ |
| Feb 13, 1984 | K834251 | HDL CHOLESTEROL PRETREATMENT American Monitor Corp. | LBR |
| Jan 30, 1984 | K834248 | PARALLEL FLAME PHOTOMETER & SODIUM American Monitor Corp. | JGT |
| Jan 30, 1984 | K834033 | KINETIC ALKALINE PHOSPHATASE American Monitor Corp. | CJE |
| Jan 18, 1984 | K833781 | DURAZYME CPK American Monitor Corp. | CGS |
| Jan 13, 1984 | K833009 | OMNI-FAL I & II American Monitor Corp. | JJY |
| Dec 29, 1983 | K833724 | ENZYMATIC CO2 American Monitor Corp. | CIL |
| May 25, 1983 | K831202 | SERUM UIBC-PTF-600 METHOD American Monitor Corp. | JMO |
| May 25, 1983 | K831201 | SERUM IRON-PTF-600 American Monitor Corp. | JIY |
| Apr 5, 1983 | K830616 | ACTIVATED URIC ACID American Monitor Corp. | CHD |
| Mar 24, 1983 | K830447 | KINETIC CREATININE American Monitor Corp. | CGX |
| Jan 7, 1983 | K823687 | BIO INTERFERENCE BLANKING MATERIAL American Monitor Corp. | JJX |
| Jul 27, 1982 | K822079 | ENZYMATIC CO2 American Monitor Corp. | KHS |
| Jul 20, 1982 | K821905 | BIURET (COLORIMETRIC) TOTAL PROTEIN American Monitor Corp. | CEK |
| May 28, 1982 | K821452 | DURAZYME CPK American Monitor Corp. | |
| Apr 15, 1982 | K820832 | PHOSPHORUS IL American Monitor Corp. | CED |
| Mar 11, 1982 | K820473 | ENZYMATIC CHOLESTEROL REAGENT SYSTEM American Monitor Corp. | CHH |
| Feb 12, 1982 | K820235 | TPTZ CHLORIDE American Monitor Corp. | CHJ |
| Dec 8, 1981 | K813215 | Y-GLUTAMYLTRANSFERASE American Monitor Corp. | |
| Nov 16, 1981 | K813076 | PHOSPHOTUNGSTATE REDUCTION, URIC ACID American Monitor Corp. | CDH |
| Feb 26, 1981 | K810434 | GAMMA-GT REAGENT SYSTEM American Monitor Corp. | JQB |
Newest 50 of 73.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||