Shared Systems, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Shared Systems, Inc.” (first 1992, latest 1998), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 112 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 |
|---|---|---|---|
| DCN | System, Test, C-Reactive Protein | 1 | 1 |
| DHR | System, Test, Rheumatoid Factor | 1 | 1 |
| GMZ | Antigens, All Types, Escherichia Coli | 1 | 1 |
| GSA | Antisera, All Mycoplasma Spp. | 1 | 1 |
| LJZ | Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp. | 1 | 1 |
Review panels
- Microbiology (3)
- Immunology (2)
Most recent Shared Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K973457 | CHROMALEX E. COLI 0157 LATEX TEST SYSTEM, PROD. NO. 800 | GMZ | 1998-01-02 | 112 |
| K955042 | CHROMALEX C-REACTIVE PROTEIN LATEX TEST SYSTEM | DCN | 1995-12-13 | 40 |
| K950073 | MYCOPLASMA PNEUMONIAE ANTIBODY LATEX AGGLUTINATION TEST SYSTEM | GSA | 1995-10-17 | 281 |
| K953261 | CHROMALEX RHEUMATOID FACTOR LATEX TEST SYSTEM | DHR | 1995-08-15 | 34 |
| K920212 | MYCOPLASMA PNEUMONIAE ANTIBODY EIA TEST SYSTEM | LJZ | 1992-08-20 | 217 |
Recalls
openFDA lists no recalls under a recalling firm named Shared Systems, 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.
- Shared P.E.T. Imaging, LLC (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Shared Systems, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Shared Systems, Inc.” (first 1992, latest 1998), across 5 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 Shared Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Shared Systems, Inc. is 112 days.
Which FDA product codes appear under Shared Systems, Inc.?
The most frequent FDA product codes under this applicant name are DCN (System, Test, C-Reactive Protein, 1); DHR (System, Test, Rheumatoid Factor, 1); GMZ (Antigens, All Types, Escherichia Coli, 1).
Next steps
- See all 5 Shared Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DCN, Shared Systems, 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, 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.