Data / Medical devices / United States / Regenlab USA LLC
Regenlab USA LLC: FDA-registered device maker in Jersey City, NJ, United States, 3 510(k) clearances
Regenlab USA LLC is registered with the FDA (registration 3010512490) in Jersey City, NJ, United States. It lists 8 device types. The FDA files 3 510(k) clearances under its listings, the newest dated June 7, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010512490
- Address
- 95 Greene St, Jersey City, NJ, United States, 07302
- Owner or operator
- RegenLab (10033110)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler
- First device listed
- July 13, 2010
- Registered through
- 2026
- Brand names listed
- A-CP-Kit Family Kits, CuteCell in vitro, RegenBMC, RegenET (ref: R-ET-3, R-ET-3 x 10), RegenKit - THT, RegenKit-BCT Family Kits:, RegenKit-BCT-1 Plus, RegenKit-BCT-2 Plus and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bottle, Roller, Tissue Culture | KJC | 1 | Contract manufacturer | accessdata.fda.gov |
| Dressing, Wound, Occlusive | NAD | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Media And Components, Synthetic Cell And Tissue Culture | KIT | 1 | Contract manufacturer | accessdata.fda.gov |
| Peripheral Blood Processing Device For Wound Management | PMQ | 2 | Manufacturer | accessdata.fda.gov |
| Platelet And Plasma Separator For Bone Graft Handling | ORG | 2 | Manufacturer | accessdata.fda.gov |
| Set, I.V. Fluid Transfer | LHI | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | Manufacturer | accessdata.fda.gov |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | 2 | Complaint file establishment, Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| June 7, 2018 | K173577 | Guarded Luer Connector | LHI | Substantially Equivalent | International Medical Industries, Inc. | accessdata.fda.gov |
| May 28, 1999 | K991088 | VACUTAINER BRAND MULTIPLE SAMPLE LUER ADAPTER, BLOOD COLLECTION SETS AND SAFETY-LOK BLOOD COLLECTION, SAFETY BLOOD COLLE | JKA | Substantially Equivalent | Becton Dickinson Vacutainer Systems | accessdata.fda.gov |
| February 10, 1997 | K965202 | VACUTAINER BRAND SAFETY-LOK BLOOD COLLECTION SET | JKA | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
Compare with other makers
- All makers of Dressing, Wound, Occlusive
- All makers of Syringe, Piston
- All makers of Tubes, Vials, Systems, Serum Separators, Blood Collection
- All makers of Set, I.V. Fluid Transfer
- All makers of Bottle, Roller, Tissue Culture
- All makers of Platelet And Plasma Separator For Bone Graft Handling
Updated June 7, 2018. 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.