Diagnostic Systems Laboratories, Inc.: FDA filings under this applicant name
FDA lists 94 510(k) clearances under the applicant name “Diagnostic Systems Laboratories, Inc.” (first 1981, latest 2006), across 40 product codes in 3 review panels. Median 510(k) review time under this name: 58 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 |
|---|---|---|---|
| CFL | Radioimmunoassay, Human Growth Hormone | 10 | 10 |
| CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone | 7 | 7 |
| JKC | Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate) | 7 | 7 |
| CEW | Radioimmunoassay, Parathyroid Hormone | 6 | 6 |
| CIZ | Radioimmunoassay, Androstenedione | 4 | 4 |
| JKR | Radioimmunoassay, Calcitonin | 4 | 4 |
| CGI | Radioimmunoassay, Estriol | 3 | 3 |
| CGR | Radioimmunoassay, Cortisol | 3 | 3 |
| CHP | Radioimmunoassay, Estradiol | 3 | 3 |
| CKG | Radioimmunoassay, Acth | 3 | 3 |
Plus 30 more product codes.
Review panels
- Clinical Chemistry (84)
- Immunology (9)
- Hematology (1)
Most recent Diagnostic Systems Laboratories, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K061758 | ACTIVE RENIN IRMA | CIB | 2006-07-28 | 36 |
| K020945 | AXSYM INTACT PTH, MODEL 2G06 | CEW | 2002-05-31 | 67 |
| K020128 | ACTIVE FREE BETA-HCG ELISA, MODEL DSL-10-8500 | JHI | 2002-03-01 | 45 |
| K002128 | ACTIVE INHIBIN-A ELISA, MODEL DSL-10-28100 | NDR | 2000-12-05 | 144 |
| K001086 | FREE TESTOSTERONE ENZYME IMMUNOASSAY, MODEL DSL-10-4900 | CDZ | 2000-05-18 | 44 |
| K990138 | DSL ACTIVE AFP ELISA, MODEL DSL-10-8400 | LOJ | 1999-06-21 | 153 |
| K981871 | C-REACTIVE PROTEIN ELISA, MODEL NUMBER DSL-10-42100 | DCK | 1998-11-09 | 165 |
| K973244 | ACTIVE PSA IRMA (DSL-9700) | LTJ | 1998-08-03 | 339 |
| K973243 | ACTIVE PSA ELISA (DSL-10-9700) | LTJ | 1998-08-03 | 339 |
| K981607 | ACTIVE RENIN IRMA MODEL NUMBER DSL-25100 | CIB | 1998-05-27 | 22 |
84 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Diagnostic Systems Laboratories, 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.
- Diagnostic Products Corp. (324 510(k)s)
- Diagnostic Chemicals, Ltd. (Usa) (77 510(k)s)
- Diagnostic Chemicals , Ltd. (66 510(k)s)
- Diagnostic Reagents, Inc. (66 510(k)s)
- Diagnostic Hybrids, Inc. (36 510(k)s)
- Diagnostic Technology, Inc. (28 510(k)s)
- Diagnostic Solutions, Inc. (26 510(k)s)
- Diagnostic Ultrasound Corp. (16 510(k)s)
- Diagnostic Systems (14 510(k)s)
- Diagnostic Reagent Tech. (10 510(k)s)
- Diagnostic Specialties (8 510(k)s)
- Diagnostic Medical Instruments (5 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Diagnostic Systems Laboratories, Inc.?
FDA lists 94 510(k) clearances under the applicant name “Diagnostic Systems Laboratories, Inc.” (first 1981, latest 2006), across 40 product codes in 3 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 Diagnostic Systems Laboratories, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Diagnostic Systems Laboratories, Inc. is 58 days.
Which FDA product codes appear under Diagnostic Systems Laboratories, Inc.?
The most frequent FDA product codes under this applicant name are CFL (Radioimmunoassay, Human Growth Hormone, 10); CDZ (Radioimmunoassay, Testosterones And Dihydrotestosterone, 7); JKC (Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate), 7).
Next steps
- See all 94 Diagnostic Systems Laboratories, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CFL, Diagnostic Systems Laboratories, 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 (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.