Data / Medical devices / United States / Human Biosciences, Inc.
Human Biosciences, Inc.: FDA-registered device maker in Martinsburg, WV, United States, 6 510(k) clearances
Human Biosciences, Inc. is registered with the FDA (registration 3008770963) in Martinsburg, WV, United States. It lists 5 device types. The FDA files 6 510(k) clearances under its listings, the newest dated December 15, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008770963
- Address
- 600 N Queen St, Martinsburg, WV, United States, 25404
- Owner or operator
- Human Biosciences, Inc. (10034299)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- November 22, 2010
- Registered through
- 2026
- Brand names listed
- Cellufil CF2001, Cellufill CF2001, Celluheal Calcium Alginate Dressing, Cellusheet CS1022, Cellusheet CS1077, Collatek Collagen Gel, Collecule LpH Collagen Pad CSP1045, Collecule LpH Surgical Collagen Powder CSP1001 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dressing, Compression | MHW | 1 | Repackager or relabeler | accessdata.fda.gov |
| Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic | MGQ | U | Manufacturer | accessdata.fda.gov |
| Dressing, Wound, Hydrophilic | NAC | 1 | Repackager or relabeler | accessdata.fda.gov |
| Dressing, Wound, Occlusive | NAD | 1 | Repackager or relabeler | accessdata.fda.gov |
| Wound Dressing With Animal-Derived Material(S) | KGN | U | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| December 15, 2021 | K213092 | Cellusheet, Cellufil | KGN | Substantially Equivalent | Human Biosciences, Inc. | accessdata.fda.gov |
| October 26, 2012 | K122325 | SKINTEMP II | KGN | Substantially Equivalent | Human Biosciences, Inc. | accessdata.fda.gov |
| December 2, 2002 | K022995 | COLLATEK HYDROGEL | MGQ | Substantially Equivalent | Biocore Medical Technologies, Inc. | accessdata.fda.gov |
| October 24, 2001 | K012990 | COLLATEK POWDER | KGN | Substantially Equivalent | Biocore Medical Technologies, Inc. | accessdata.fda.gov |
| October 2, 1991 | K913023 | SKINTEMP | KGN | Substantially Equivalent | Biocore | accessdata.fda.gov |
| April 2, 1991 | K910944 | MEDIFIL | KGN | Substantially Equivalent | Biocore | accessdata.fda.gov |
Compare with other makers
- All makers of Wound Dressing With Animal-Derived Material(S)
- All makers of Dressing, Wound, Occlusive
- All makers of Dressing, Compression
- All makers of Dressing, Wound, Hydrophilic
- All makers of Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
Updated December 15, 2021. 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.