Data / Medical devices / United States / MML Diagnostics Packaging, Inc.
MML Diagnostics Packaging, Inc.: FDA-registered device maker in Troutdale, OR, United States, 6 510(k) clearances
MML Diagnostics Packaging, Inc. is registered with the FDA (registration 3018348) in Troutdale, OR, United States. It lists 10 device types. The FDA files 6 510(k) clearances under its listings, the newest dated August 26, 2009. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3018348
- Address
- 1625 NW Sundial RD., Troutdale, OR, United States, 97060
- Owner or operator
- MML Diagnostics Packaging (3018348)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler
- First device listed
- May 11, 2015
- Registered through
- 2026
- Brand names listed
- MML Specimen Collection Swab
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Blood Circuit, Hemodialysis | KOC | 2 | Repackager or relabeler | accessdata.fda.gov |
| Applicator, Absorbent Tipped, Sterile | KXG | 1 | Manufacturer | accessdata.fda.gov |
| Clamp, Vascular | DXC | 2 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Container, Specimen Mailer And Storage, Non-Sterile | NNK | 1 | Contract manufacturer | accessdata.fda.gov |
| Culture Media, Non-Propagating Transport | JSM | 1 | Contract manufacturer | accessdata.fda.gov |
| Device, Specimen Collection | LIO | 1 | Contract manufacturer | accessdata.fda.gov |
| Dna-Reagents, Neisseria | LSL | 2 | Contract manufacturer | accessdata.fda.gov |
| Dressing, Wound, Drug | FRO | U | Repackager or relabeler | accessdata.fda.gov |
| Sampler, Amniotic Fluid (Amniocentesis Tray) | HIO | 1 | Repackager or relabeler | accessdata.fda.gov |
| Wound Dressing With Animal-Derived Material(S) | KGN | U | 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 |
|---|---|---|---|---|---|---|
| August 26, 2009 | K091338 | COLLASORB COLLAGEN WOUND DRESSING | KGN | Substantially Equivalent | Hartmann-Conco, Inc. | accessdata.fda.gov |
| March 12, 2009 | K081740 | HEMOBAND, MODELS HB-NS AND HB-NSXL | KOC | Substantially Equivalent | Innovations For Access, Inc. | accessdata.fda.gov |
| April 25, 2008 | K071552 | PURACOL PLUS AG COLLAGEN MICROSCAFFOLD WOUND DRESSING | FRO | Substantially Equivalent | Medline Industries, Inc. | accessdata.fda.gov |
| June 19, 2006 | K060456 | MEDLINE COLLAGEN WOUND DRESSING | KGN | Substantially Equivalent | Medline Industries, Inc. | accessdata.fda.gov |
| December 11, 1997 | K964663 | FAVP: FEMORAL ARTERY VASCULAR PAD - MODEL NUMBER PAD2EK-01, PAD2EK-2X, PAD5EK-R, PAD5EK-RX, PAD6EK-F AND PAD6EK-FX | DXC | Substantially Equivalent | Rmds, Inc. | accessdata.fda.gov |
| September 1, 1993 | K914419 | AMNIOTEST(TM) | HIO | Substantially Equivalent | Pro-Lab, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Clamp, Vascular
- All makers of Device, Specimen Collection
- All makers of Sampler, Amniotic Fluid (Amniocentesis Tray)
- All makers of Wound Dressing With Animal-Derived Material(S)
- All makers of Culture Media, Non-Propagating Transport
- All makers of Applicator, Absorbent Tipped, Sterile
Updated August 26, 2009. 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.