Data / Medical devices / United States / Rodimedi & Associates Inc.
Rodimedi & Associates Inc.: FDA-registered device maker in Alt de San Lorenzo, PR, United States, 7 510(k) clearances
Rodimedi & Associates Inc. is registered with the FDA (registration 3011287770) in Alt de San Lorenzo, PR, United States. It lists 9 device types. The FDA files 7 510(k) clearances under its listings, the newest dated July 30, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011287770
- Address
- Carr. 181, 201 Calle Jose de Diego Plaza Rodimedi, Alt de San Lorenzo, PR, United States, 00754
- Owner or operator
- RODIMEDI & ASSOCIATES INC. (10082352)
- Roles
- Complaint file establishment, Repackager or relabeler
- First device listed
- July 15, 2021
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus | GQG | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Medical Glove, Specialty | LZC | 1 | Complaint file establishment | accessdata.fda.gov |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | 1 | Complaint file establishment | accessdata.fda.gov |
| Needle, Hypodermic, Single Lumen | FMI | 2 | Complaint file establishment | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Complaint file establishment | accessdata.fda.gov |
| Reagent, Occult Blood | KHE | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Syringe, Antistick | MEG | 2 | Repackager or relabeler | accessdata.fda.gov |
| Test, Erythrocyte Sedimentation Rate | JPH | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | 2 | Complaint file establishment | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 30, 2024 | K240280 | Nano-Check RSV Test | GQG | Substantially Equivalent | Nano-Ditech Corporation | accessdata.fda.gov |
| March 18, 2022 | K220228 | Powder Free Nitrile Examination Gloves, Blue and Violet Blue, Test For Use With Chemotherapy Drugs | LZA | Substantially Equivalent | Shandong Blue Sail Health Technology Co., Ltd. | accessdata.fda.gov |
| August 17, 2021 | K211708 | Disposable Medical Nitrile Gloves | LZA | Substantially Equivalent | Jiangsu Health-Peace Medical Technology Co., Ltd. | accessdata.fda.gov |
| September 9, 2020 | K200027 | Blood Collection Needle with/without Holder, Safety Blood Collection Needle with/without Holder, Luer Access Device-holder with Preattached Multiple Sample Adapter | JKA | Substantially Equivalent | Jiangsu Caina Medical Co.,Ltd | accessdata.fda.gov |
| March 14, 2017 | K163093 | Safety Blood Collection Set | FMI | Substantially Equivalent | Jiangsu Shenli Medical Production Co., Ltd. | accessdata.fda.gov |
| February 20, 2015 | K142435 | 3S Safety Syringe with/without Needle | MEG | Substantially Equivalent | Sincere Medical Device Co., Ltd. | accessdata.fda.gov |
| September 14, 2011 | K110309 | FOB ONE STEP RAPID TEST | KHE | Substantially Equivalent | Orient Gene Biotech | accessdata.fda.gov |
Compare with other makers
- All makers of Needle, Hypodermic, Single Lumen
- All makers of Tubes, Vials, Systems, Serum Separators, Blood Collection
- All makers of Medical Glove, Specialty
- All makers of Polymer Patient Examination Glove
- All makers of Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs
- All makers of Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus
Updated July 30, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.