Diazyme Laboratories: FDA filings under this applicant name
FDA lists 52 510(k) clearances under the applicant name “Diazyme Laboratories” (first 2003, latest 2026), across 29 product codes in 5 review panels. Median 510(k) review time under this name: 139 days. Since 2017 the median was 249 days, against 210 days for all cleared 510(k)s in the same product codes. 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 | 4 | 116 |
| 2013 | 3 | 179 |
| 2014 | 3 | 233 |
| 2015 | 0 | — |
| 2016 | 5 | 245 |
| 2017 | 2 | 250 |
| 2018 | 4 | 88 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 2 | 220 |
| 2022 | 2 | 340 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 2 | 173 |
| 2026 | 2 | 268 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Diazyme Laboratories took a median 249 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 210 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DFH | Kappa, Antigen, Antiserum, Control | 5 | 5 |
| LCP | Assay, Glycosylated Hemoglobin | 5 | 5 |
| LPS | Urinary Homocystine (Nonquantitative) Test System | 4 | 4 |
| MRG | System, Test, Vitamin D | 4 | 4 |
| MZV | Test, System, Potassium, Enzymatic Method | 3 | 3 |
| NDY | Test, Cystatin C | 3 | 3 |
| DCK | C-Reactive Protein, Antigen, Antiserum, And Control | 2 | 2 |
| DFC | Lipoprotein, Low-Density, Antigen, Antiserum, Control | 2 | 2 |
| DHA | System, Test, Human Chorionic Gonadotropin | 2 | 2 |
| JIT | Calibrator, Secondary | 2 | 2 |
Plus 19 more product codes.
Review panels
- Clinical Chemistry (28)
- Immunology (12)
- Hematology (8)
- Clinical Toxicology (2)
- Microbiology (1)
Most recent Diazyme Laboratories 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253069 | Lipoprotein (a) Molarity Assay | DFC | 2026-06-16 | 266 |
| K252336 | Diazyme Immunoglobulin A Assay; Diazyme Immunoglobulin G Assay; Diazyme Immunoglobulin M Assay | — | 2026-04-24 | 270 |
| K253358 | Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain Assay | DFH | 2025-12-19 | 80 |
| K243462 | Diazyme Colorimetric Lithium Assay | NDW | 2025-08-01 | 266 |
| K211648 | Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay | DFH | 2022-09-08 | 468 |
| K220001 | Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay | DFH | 2022-08-04 | 212 |
| K212221 | Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay Analyzer | DHA | 2021-12-13 | 150 |
| K203136 | Diazyme PLAC® Test for Lp-PLA2 Activity | NOE | 2021-08-06 | 290 |
| K180209 | Diazyme 1,5-AG Assay | NOZ | 2018-10-04 | 253 |
| K181438 | Diazyme Human Kappa Free Light Chain Assay; Diazyme Human Lambda Free Light Chain Assay | DFH | 2018-06-26 | 25 |
42 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Diazyme Laboratories.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Diazyme Laboratories?
FDA lists 52 510(k) clearances under the applicant name “Diazyme Laboratories” (first 2003, latest 2026), across 29 product codes in 5 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 Diazyme Laboratories?
The median time from FDA receipt to decision across 510(k)s cleared under the name Diazyme Laboratories is 139 days. Since 2017: 249 days, versus 210 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Diazyme Laboratories?
The most frequent FDA product codes under this applicant name are DFH (Kappa, Antigen, Antiserum, Control, 5); LCP (Assay, Glycosylated Hemoglobin, 5); LPS (Urinary Homocystine (Nonquantitative) Test System, 4).
Next steps
- See all 52 Diazyme Laboratories clearances with predicates and recalls
- Run predicate analysis for product code DFH, Diazyme Laboratories'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.