Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
American Monitor Corp. · Predicate Candidate Screening
73 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
35 daysmedian FDA review time
79 days90th percentile
73clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K895999 | PHOSPHORUS | American Monitor Corp. | 1990-01-11 | 90 | 0 |
| K896000 | ASPARTATE AMINOTRANFERASE (AST) | American Monitor Corp. | 1990-01-11 | 90 | 0 |
| K896001 | ALANINE AMINOTRANSFERASE (ALT) | American Monitor Corp. | 1989-11-13 | 31 | 0 |
| K895423 | ACCESS CHEMISTRY ANALYZER | American Monitor Corp. | 1989-10-04 | 27 | 0 |
| K893137 | EXCEL (TM) CHEMISTRY ANALYZER | American Monitor Corp. | 1989-08-10 | 107 | 0 |
| K892331 | ENZYMATIC UREA NITROGEN REAGENT SET | American Monitor Corp. | 1989-06-20 | 76 | 0 |
| K893479 | CHOLESTEROL REAGENT SET | American Monitor Corp. | 1989-06-19 | 46 | 0 |
| K892002 | NEOCHROME(R) III GLUCOSE | American Monitor Corp. | 1989-06-12 | 76 | 0 |
| K890312 | GAMMA-GLUTAMYLTRANSFERASE | American Monitor Corp. | 1989-03-24 | 60 | 0 |
| K890034 | PHOTOMETRIC METHOD, IRON (NON-HEME) (75JIY) | American Monitor Corp. | 1989-02-03 | 30 | 0 |
| K883504 | DURAZYME(R) CPK | American Monitor Corp. | 1988-09-13 | 27 | 0 |
| K882497 | ENZYMATIC CO2 REAGENT SET | American Monitor Corp. | 1988-08-02 | 46 | 0 |
| K873074 | SODIUM AND POTASSIUM BY ION SELECTIVE | American Monitor Corp. | 1987-10-20 | 75 | 0 |
| K872073 | BIO-INTERFERENCE BLANKING MATERIAL, AM CAT. #2052 | American Monitor Corp. | 1987-09-11 | 105 | 0 |
| K872181 | ETHANOL CALIBRATOR | American Monitor Corp. | 1987-07-21 | 43 | 0 |
| K872180 | KINETIC 610 ETHANOL | American Monitor Corp. | 1987-07-07 | 29 | 0 |
| K871301 | ENZYMATIC TRIGLYCERIDES GPO-TRINDER METHOD | American Monitor Corp. | 1987-04-22 | 21 | 0 |
| K870277 | MONITORX LASERX THEOPHYLLINE REAGENT SET | American Monitor Corp. | 1987-02-18 | 22 | 0 |
| K862963 | THERAPEUTIC DRUG MONITORING CONTROL SET | American Monitor Corp. | 1986-09-15 | 40 | 0 |
| K862964 | ANTIASTHMATIC CALIBRATORS | American Monitor Corp. | 1986-08-19 | 13 | 0 |
| K854789 | RANGE-CHEK | American Monitor Corp. | 1986-01-13 | 45 | 0 |
| K854366 | ENZYMATIC TRIGLYCERIDES GPO-GRINDER METHOD | American Monitor Corp. | 1985-11-25 | 27 | 0 |
| K854553 | TOTAL PROTEIN | American Monitor Corp. | 1985-11-25 | 12 | 0 |
| K852292 | DURAZYME UREA NITROGEN | American Monitor Corp. | 1985-07-08 | 40 | 0 |
| K852350 | HDL CHOLESTEROL PRETREATMENT | American Monitor Corp. | 1985-07-08 | 38 | 0 |
| K843610 | PERSPECTIVE CHEMICAL ANALYZER | American Monitor Corp. | 1984-10-05 | 22 | 0 |
| K843611 | QUALIFY I & II AMER. MONITOR 2009 & 2010 | American Monitor Corp. | 1984-09-28 | 15 | 0 |
| K843008 | ION SELECTIVE ELECTRODES & REAGENT SYS | American Monitor Corp. | 1984-09-04 | 35 | 0 |
| K840368 | DURAZYME CHOLESTEROL | American Monitor Corp. | 1984-03-30 | 63 | 0 |
| K840006 | KINETIC LDH, A< BLUE 610 METHOD | American Monitor Corp. | 1984-03-23 | 79 | 0 |
| K834251 | HDL CHOLESTEROL PRETREATMENT | American Monitor Corp. | 1984-02-13 | 68 | 0 |
| K834033 | KINETIC ALKALINE PHOSPHATASE | American Monitor Corp. | 1984-01-30 | 68 | 0 |
| K834248 | PARALLEL FLAME PHOTOMETER & SODIUM | American Monitor Corp. | 1984-01-30 | 54 | 0 |
| K833781 | DURAZYME CPK | American Monitor Corp. | 1984-01-18 | 82 | 0 |
| K833009 | OMNI-FAL I & II | American Monitor Corp. | 1984-01-13 | 129 | 0 |
| K833724 | ENZYMATIC CO2 | American Monitor Corp. | 1983-12-29 | 66 | 0 |
| K831201 | SERUM IRON-PTF-600 | American Monitor Corp. | 1983-05-25 | 42 | 0 |
| K831202 | SERUM UIBC-PTF-600 METHOD | American Monitor Corp. | 1983-05-25 | 42 | 0 |
| K830616 | ACTIVATED URIC ACID | American Monitor Corp. | 1983-04-05 | 36 | 0 |
| K830447 | KINETIC CREATININE | American Monitor Corp. | 1983-03-24 | 42 | 0 |
| K823687 | BIO INTERFERENCE BLANKING MATERIAL | American Monitor Corp. | 1983-01-07 | 31 | 0 |
| K822079 | ENZYMATIC CO2 | American Monitor Corp. | 1982-07-27 | 12 | 0 |
| K821905 | BIURET (COLORIMETRIC) TOTAL PROTEIN | American Monitor Corp. | 1982-07-20 | 22 | 0 |
| K821452 | DURAZYME CPK | American Monitor Corp. | 1982-05-28 | 14 | 0 |
| K820832 | PHOSPHORUS IL | American Monitor Corp. | 1982-04-15 | 20 | 0 |
| K820473 | ENZYMATIC CHOLESTEROL REAGENT SYSTEM | American Monitor Corp. | 1982-03-11 | 20 | 0 |
| K820235 | TPTZ CHLORIDE | American Monitor Corp. | 1982-02-12 | 15 | 0 |
| K813215 | Y-GLUTAMYLTRANSFERASE | American Monitor Corp. | 1981-12-08 | 29 | 0 |
| K813076 | PHOSPHOTUNGSTATE REDUCTION, URIC ACID | American Monitor Corp. | 1981-11-16 | 14 | 0 |
| K810434 | GAMMA-GT REAGENT SYSTEM | American Monitor Corp. | 1981-02-26 | 7 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda