Diagnostic Products Corp.: FDA clearances and approvals
Diagnostic Products Corp. has 324 FDA 510(k) clearances (first 1976, latest 2006), across 118 product codes in 8 review panels. Median 510(k) review time: 50 days. openFDA lists 7 product recalls by a recalling firm named Diagnostic Products Corp.
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 |
|---|---|---|---|
| DHB | System, Test, Radioallergosorbent (Rast) Immunological | 26 | 26 |
| CEW | Radioimmunoassay, Parathyroid Hormone | 10 | 10 |
| CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone | 9 | 9 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 9 | 9 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 8 | 8 |
| CDD | Radioassay, Vitamin B12 | 6 | 6 |
| CDP | Radioimmunoassay, Total Triiodothyronine | 6 | 6 |
| CFT | Radioimmunoassay, Prolactin (Lactogen) | 6 | 6 |
| DGC | Ige, Antigen, Antiserum, Control | 6 | 6 |
| DJG | Enzyme Immunoassay, Opiates | 6 | 6 |
Plus 108 more product codes.
Review panels
- Clinical Chemistry (156)
- Clinical Toxicology (69)
- Immunology (66)
- Microbiology (24)
- Hematology (3)
- Pathology (3)
- Dental (1)
- General and Plastic Surgery (1)
Most recent Diagnostic Products Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K063057 | IMMULITE/IMMULITE 1000, IMMULITE 2000 HIGH SENSITIVITY CRP | NQD | 2006-12-22 | 78 |
| K063045 | IMMULITE 2000, IMMULITE 2500 VANCOMYCIN | LEH | 2006-12-05 | 62 |
| K060929 | IMMULITE 2500 VITAMIN B12 MODEL L5KVB2-200 TEST,L5KVB6-600 TEST, IMMULITE 2500 FOLIC ACID MODEL L5KFO2-200 TEST,L5KFO6-6 | CDD | 2006-04-28 | 23 |
| K053533 | IMMULITE/IMMULITE 1000 TURBO INTACT PTH | CEW | 2006-02-03 | 46 |
| K034055 | IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN I | JHX | 2004-01-21 | 22 |
| K033234 | IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZER | DHA | 2003-12-12 | 67 |
| K032881 | IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONE | CDZ | 2003-10-10 | 25 |
| K023152 | IMMULITE 2000 ALLERGEN-SPECIFIC IGE | DHB | 2002-12-17 | 85 |
| K023304 | IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODEL L2KCL | JKR | 2002-12-09 | 67 |
| K022603 | IMMULITE 1000 AUTOMATED IMMUNOASSAY ANALYZER | CEW | 2002-08-21 | 15 |
314 earlier clearances. See the full list in Caduvo.
Recalls
7 product recalls in 7 recall events; 0 initiated in the last five years. Most recent: 2006-01-03.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Diagnostic Products Corp. have?
Diagnostic Products Corp. has 324 FDA 510(k) clearances (first 1976, latest 2006), across 118 product codes in 8 review panels.
How long does FDA take to clear Diagnostic Products Corp.'s 510(k)s?
The median time from FDA receipt to decision across Diagnostic Products Corp.'s cleared 510(k)s is 50 days.
What devices does Diagnostic Products Corp. make?
Its most frequent FDA product codes are DHB (System, Test, Radioallergosorbent (Rast) Immunological, 26); CEW (Radioimmunoassay, Parathyroid Hormone, 10); CDZ (Radioimmunoassay, Testosterones And Dihydrotestosterone, 9).
Has Diagnostic Products Corp. had device recalls?
openFDA lists 7 product recalls in 7 recall events by a recalling firm whose name matches Diagnostic Products Corp; the most recent began 2006-01-03. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 324 Diagnostic Products Corp. clearances with predicates and recalls
- Run predicate analysis for product code DHB, Diagnostic Products Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.