Genzyme Diagnostics: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Genzyme Diagnostics” (first 1996, latest 2005), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 105 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 |
|---|---|---|---|
| JHI | Visual, Pregnancy Hcg, Prescription Use | 3 | 3 |
| KTN | System, Test, Infectious Mononucleosis | 1 | 1 |
| MHI | Giardia Spp. | 1 | 1 |
Review panels
- Clinical Chemistry (3)
- Microbiology (2)
Most recent Genzyme Diagnostics 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K043385 | OSOM HCG COMBO TEST | JHI | 2005-04-12 | 124 |
| K983399 | GIARDIA/CRYPTOSPORIDIUM COMBO RAPID ASSAY | MHI | 1999-01-11 | 105 |
| K963425 | GENZYME DIAGNOSTICS CONTRAST MONO | KTN | 1997-02-25 | 179 |
| K964156 | CONTRAST STRIP HCG | JHI | 1996-11-25 | 40 |
| K964155 | CONTRAST HCG URINE/SERUM TEST AND RAPID HCG URINE/SERUM TEST | JHI | 1996-11-25 | 40 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2004-02-23.
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.
- Genzyme Corp. (33 510(k)s)
- Genzyme Surgical Product (Genzyme Biosurgery) (9 510(k)s)
- Genzyme Biosurgery (4 510(k)s)
- Genzyme Diagnostics P.E.I., Inc. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Genzyme Diagnostics?
FDA lists 5 510(k) clearances under the applicant name “Genzyme Diagnostics” (first 1996, latest 2005), across 3 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 Genzyme Diagnostics?
The median time from FDA receipt to decision across 510(k)s cleared under the name Genzyme Diagnostics is 105 days.
Which FDA product codes appear under Genzyme Diagnostics?
The most frequent FDA product codes under this applicant name are JHI (Visual, Pregnancy Hcg, Prescription Use, 3); KTN (System, Test, Infectious Mononucleosis, 1); MHI (Giardia Spp., 1).
Next steps
- See all 5 Genzyme Diagnostics clearances with predicates and recalls
- Run predicate analysis for product code JHI, Genzyme 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, 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.