Company ยท US
Advanced Biomedical Methods, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1976 to 1994. Name variants (Inc, Corp, punctuation) are merged.
21510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CGA | Glucose Oxidase, Glucose | 2 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 2 |
| CIC | Cresolphthalein Complexone, Calcium | 2 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | 2 |
| CDL | Berthelot Indophenol, Urea Nitrogen | 1 |
| CEK | Biuret (Colorimetric), Total Protein | 1 |
| CEO | Phosphomolybdate (Colorimetric), Inorganic Phosphorus | 1 |
| CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | 1 |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 1 |
| CGZ | Electrode, Ion-Specific, Chloride | 1 |
| CIG | Diazo Colorimetry, Bilirubin | 1 |
| CIT | Nadh Oxidation/Nad Reduction, Ast/Sgot | 1 |
| CIX | Bromcresol Green Dye-Binding, Albumin | 1 |
| CJE | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | 1 |
| CJY | Azo Dye, Calcium | 1 |
| DKJ | Colorimetry, Salicylate | 1 |
| JGJ | Photometric Method, Magnesium | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 9, 1994 | K945353 | CLARIT(TM) Advanced Biomedical Methods, Inc. | JKA |
| Apr 5, 1988 | K880949 | SINGLE REAGENT CALCIUM FOR DEMAND ANALYZER Advanced Biomedical Methods, Inc. | CJY |
| Mar 16, 1987 | K864866 | RESUBMISSION OF THE KLEERZIT REAGENT Advanced Biomedical Methods, Inc. | JKA |
| Jul 22, 1985 | K852784 | ALKALINE PHOSPHATASE Advanced Biomedical Methods, Inc. | CJE |
| Jul 22, 1985 | K852783 | SGOT/ALT REAGENT Advanced Biomedical Methods, Inc. | CIT |
| May 29, 1985 | K852027 | GGTP REAGENT/SERUM IRON/SALICYLATE DEMAND ANALYZER Advanced Biomedical Methods, Inc. | DKJ |
| Mar 1, 1985 | K850381 | MAGNESIUM REAGENT FOR DEMAND ANALYZER Advanced Biomedical Methods, Inc. | JGJ |
| Mar 1, 1985 | K850380 | INORGANIC PHOSPHOROUS FOR DEMAND ANALYZER Advanced Biomedical Methods, Inc. | CEO |
| Mar 1, 1985 | K850379 | DIRECT BILIRUBIN FOR DEMAND ANALYZER Advanced Biomedical Methods, Inc. | CIG |
| Mar 1, 1985 | K850378 | LDH REAGENT FOR DEMAND ANALYZER Advanced Biomedical Methods, Inc. | CFJ |
| Jan 3, 1985 | K844332 | CREATININE REAGENT FOR DEMAND ANALYZER Advanced Biomedical Methods, Inc. | CGX |
| Jan 3, 1985 | K844331 | TOTAL PROTEIN REAGENT FOR DEMAND ANALYZER Advanced Biomedical Methods, Inc. | CEK |
| Jan 3, 1985 | K844330 | ALBUMIN REAGENT FOR DEMAND ANALYZER Advanced Biomedical Methods, Inc. | CIX |
| Jan 3, 1985 | K844243 | TOTAL BILIRUBIN FOR DEMAND ANALYZER Advanced Biomedical Methods, Inc. | CIC |
| Jan 3, 1985 | K844242 | CHOLESTEROL REAGENT FOR DEMAND ANALYZER Advanced Biomedical Methods, Inc. | CHH |
| Jan 3, 1985 | K844241 | CALCIUM REAGENT FOR DEMAND ANALYZER Advanced Biomedical Methods, Inc. | CIC |
| Dec 10, 1984 | K844021 | ISE REAGENTS FOR DEMAND ANALYZER Advanced Biomedical Methods, Inc. | CGZ |
| Sep 15, 1977 | K771586 | CHOLOPAP-HDL Advanced Biomedical Methods, Inc. | CHH |
| Dec 9, 1976 | K761154 | GLUCOSE OXIDASE REAG FOR BECKMAN ANALYZ Advanced Biomedical Methods, Inc. | CGA |
| Dec 9, 1976 | K761153 | GLUC OPAP, IN VITRO DIAG. FOR GLUCOSE Advanced Biomedical Methods, Inc. | CGA |
| Dec 9, 1976 | K761152 | S-UREA-N, IN VITRO DIAG FOR BUN Advanced Biomedical Methods, Inc. | CDL |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||