Advanced Biomedical Methods, Inc.: FDA filings under this applicant name
FDA lists 21 510(k) clearances under the applicant name “Advanced Biomedical Methods, Inc.” (first 1976, latest 1994), across 17 product codes in 2 review panels. Median 510(k) review time under this name: 29 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| CGA | Glucose Oxidase, Glucose | 2 | 2 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 2 | 2 |
| CIC | Cresolphthalein Complexone, Calcium | 2 | 2 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | 2 | 2 |
| CDL | Berthelot Indophenol, Urea Nitrogen | 1 | 1 |
| CEK | Biuret (Colorimetric), Total Protein | 1 | 1 |
| CEO | Phosphomolybdate (Colorimetric), Inorganic Phosphorus | 1 | 1 |
| CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | 1 | 1 |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 1 | 1 |
| CGZ | Electrode, Ion-Specific, Chloride | 1 | 1 |
Plus 7 more product codes.
Review panels
Most recent Advanced Biomedical Methods, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K945353 | CLARIT(TM) | JKA | 1994-12-09 | 50 |
| K880949 | SINGLE REAGENT CALCIUM FOR DEMAND ANALYZER | CJY | 1988-04-05 | 29 |
| K864866 | RESUBMISSION OF THE KLEERZIT REAGENT | JKA | 1987-03-16 | 95 |
| K852784 | ALKALINE PHOSPHATASE | CJE | 1985-07-22 | 21 |
| K852783 | SGOT/ALT REAGENT | CIT | 1985-07-22 | 21 |
| K852027 | GGTP REAGENT/SERUM IRON/SALICYLATE DEMAND ANALYZER | DKJ | 1985-05-29 | 21 |
| K850381 | MAGNESIUM REAGENT FOR DEMAND ANALYZER | JGJ | 1985-03-01 | 29 |
| K850380 | INORGANIC PHOSPHOROUS FOR DEMAND ANALYZER | CEO | 1985-03-01 | 29 |
| K850379 | DIRECT BILIRUBIN FOR DEMAND ANALYZER | CIG | 1985-03-01 | 29 |
| K850378 | LDH REAGENT FOR DEMAND ANALYZER | CFJ | 1985-03-01 | 29 |
11 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Advanced Biomedical Methods, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Advanced Cardiovascular Systems, Inc. (103 510(k)s)
- Advanced Surgical Products, Inc. (64 510(k)s)
- Advanced Technology Laboratories, Inc. (61 510(k)s)
- Advanced Sterilization Products (59 510(k)s)
- Advanced Neuromodulation Systems (25 510(k)s)
- Advanced Orthopaedic Solutions, Inc. (24 510(k)s)
- Advanced Biosearch Assn. (22 510(k)s)
- Advanced Surgical, Inc. (21 510(k)s)
- Advanced Clinical Diagnostics (19 510(k)s)
- Advanced Instrumentations, Inc. (16 510(k)s)
- Advanced Instruments, Inc. (16 510(k)s)
- Advanced Spine Fixation Systems, Inc. (16 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Advanced Biomedical Methods, Inc.?
FDA lists 21 510(k) clearances under the applicant name “Advanced Biomedical Methods, Inc.” (first 1976, latest 1994), across 17 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Advanced Biomedical Methods, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Advanced Biomedical Methods, Inc. is 29 days.
Which FDA product codes appear under Advanced Biomedical Methods, Inc.?
The most frequent FDA product codes under this applicant name are CGA (Glucose Oxidase, Glucose, 2); CHH (Enzymatic Esterase--Oxidase, Cholesterol, 2); CIC (Cresolphthalein Complexone, Calcium, 2).
Next steps
- See all 21 Advanced Biomedical Methods, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CGA, Advanced Biomedical Methods, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.