Advanced Clinical Diagnostics: FDA filings under this applicant name
FDA lists 19 510(k) clearances under the applicant name “Advanced Clinical Diagnostics” (first 1988, latest 1994), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 102 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 |
|---|---|---|---|
| KIR | Cells, Animal And Human, Cultured | 18 | 18 |
| LLH | Reagents, Clostridium Difficile Toxin | 1 | 1 |
Review panels
- Pathology (18)
- Microbiology (1)
Most recent Advanced Clinical Diagnostics 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K936172 | RHESUS MONKEY KIDNEY CELLS (LLC-MK2) | KIR | 1994-02-03 | 42 |
| K936171 | TRANSFORMED PRIMARY HUMAN EMBRYONAL KIDNEY | KIR | 1994-02-03 | 42 |
| K936169 | RHESUS MONKEY KIDNEY CELLS | KIR | 1994-02-03 | 42 |
| K934973 | HELA-229/HELA CELLS | KIR | 1994-01-28 | 102 |
| K934934 | RABBIT KIDNEY CELLS - R.K.C. | KIR | 1994-01-28 | 155 |
| K935766 | PRIMARY AFRICAN GREEN MONKEY KIDNEY CELLS | KIR | 1994-01-24 | 80 |
| K935339 | HELA HELA EPITHELOID CARCINOMA | KIR | 1994-01-03 | 59 |
| K935338 | LUNG CACINOMA, HUMAN CELLS | KIR | 1994-01-03 | 59 |
| K935337 | RHABDOMYOSARCOMA CELLS | KIR | 1994-01-03 | 59 |
| K935336 | CYNOMOLOGUS MONKEY KIDNEY CELLS | KIR | 1994-01-03 | 59 |
9 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Advanced Clinical Diagnostics.
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 Medical Solutions, Ltd. (22 510(k)s)
- Advanced Biosearch Assn. (22 510(k)s)
- Advanced Biomedical Methods, Inc. (21 510(k)s)
- Advanced Surgical, Inc. (21 510(k)s)
- Advanced Instrumentations, Inc. (16 510(k)s)
- Advanced Instruments, Inc. (16 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Advanced Clinical Diagnostics?
FDA lists 19 510(k) clearances under the applicant name “Advanced Clinical Diagnostics” (first 1988, latest 1994), across 2 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 Clinical Diagnostics?
The median time from FDA receipt to decision across 510(k)s cleared under the name Advanced Clinical Diagnostics is 102 days.
Which FDA product codes appear under Advanced Clinical Diagnostics?
The most frequent FDA product codes under this applicant name are KIR (Cells, Animal And Human, Cultured, 18); LLH (Reagents, Clostridium Difficile Toxin, 1).
Next steps
- See all 19 Advanced Clinical Diagnostics clearances with predicates and recalls
- Run predicate analysis for product code KIR, Advanced Clinical Diagnostics'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.