Advanced Biomedical Methods, Inc.
Mchenry, IL, US
Advanced Biomedical Methods, Inc. appears in FDA device records in Mchenry, IL. FDA records list 21 510(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
- 21
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 21 510(k) clearances for Advanced Biomedical Methods, Inc. between 1976 and 1994. The busiest year on record is 1985, with 13. The most recent is 1994, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1976 | 3 |
| 1977 | 1 |
| 1984 | 1 |
| 1985 | 13 |
| 1987 | 1 |
| 1988 | 1 |
| 1994 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K945353 | CLARIT(TM) | JKA | Substantially Equivalent | |
| K880949 | SINGLE REAGENT CALCIUM FOR DEMAND ANALYZER | CJY | Substantially Equivalent | |
| K864866 | RESUBMISSION OF THE KLEERZIT REAGENT | JKA | Substantially Equivalent | |
| K852784 | ALKALINE PHOSPHATASE | CJE | Substantially Equivalent | |
| K852783 | SGOT/ALT REAGENT | CIT | Substantially Equivalent | |
| K852027 | GGTP REAGENT/SERUM IRON/SALICYLATE DEMAND ANALYZER | DKJ | Substantially Equivalent | |
| K850381 | MAGNESIUM REAGENT FOR DEMAND ANALYZER | JGJ | Substantially Equivalent | |
| K850380 | INORGANIC PHOSPHOROUS FOR DEMAND ANALYZER | CEO | Substantially Equivalent | |
| K850379 | DIRECT BILIRUBIN FOR DEMAND ANALYZER | CIG | Substantially Equivalent | |
| K850378 | LDH REAGENT FOR DEMAND ANALYZER | CFJ | Substantially Equivalent | |
| K844332 | CREATININE REAGENT FOR DEMAND ANALYZER | CGX | Substantially Equivalent | |
| K844331 | TOTAL PROTEIN REAGENT FOR DEMAND ANALYZER | CEK | Substantially Equivalent | |
| K844330 | ALBUMIN REAGENT FOR DEMAND ANALYZER | CIX | Substantially Equivalent | |
| K844243 | TOTAL BILIRUBIN FOR DEMAND ANALYZER | CIC | Substantially Equivalent | |
| K844242 | CHOLESTEROL REAGENT FOR DEMAND ANALYZER | CHH | Substantially Equivalent | |
| K844241 | CALCIUM REAGENT FOR DEMAND ANALYZER | CIC | Substantially Equivalent | |
| K844021 | ISE REAGENTS FOR DEMAND ANALYZER | CGZ | Substantially Equivalent | |
| K771586 | CHOLOPAP-HDL | CHH | Substantially Equivalent | |
| K761154 | GLUCOSE OXIDASE REAG FOR BECKMAN ANALYZ | CGA | Substantially Equivalent | |
| K761153 | GLUC OPAP, IN VITRO DIAG. FOR GLUCOSE | CGA | Substantially Equivalent | |
| K761152 | S-UREA-N, IN VITRO DIAG FOR BUN | CDL | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- CGXAlkaline Picrate, Colorimetry, Creatinine
- CJYAzo Dye, Calcium
- CDLBerthelot Indophenol, Urea Nitrogen
- CEKBiuret (Colorimetric), Total Protein
- CIXBromcresol Green Dye-Binding, Albumin
- DKJColorimetry, Salicylate
- CICCresolphthalein Complexone, Calcium
- CIGDiazo Colorimetry, Bilirubin
- CGZElectrode, Ion-Specific, Chloride
- CHHEnzymatic Esterase--Oxidase, Cholesterol
- CGAGlucose Oxidase, Glucose
- CFJNad Reduction/Nadh Oxidation, Lactate Dehydrogenase
- CITNadh Oxidation/Nad Reduction, Ast/Sgot
- CJENitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
- CEOPhosphomolybdate (Colorimetric), Inorganic Phosphorus
- JGJPhotometric Method, Magnesium
- JKATubes, Vials, Systems, Serum Separators, Blood Collection
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