Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3018348

FEI Number

3018348

Entity Name

MML DIAGNOSTICS PACKAGING, INC.

City/State/Country

Troutdale, OR, US

Establishment Address

1625 NW SUNDIAL RD., Troutdale, OR 97060, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

MML Diagnostics Packaging (Owner Number: 3018348)

Owner / Operator Contact Address

1625 N.W. SUNDIAL RD., --, Troutdale, OR 97060, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K060456

PMA Number

N/A

All Registered Proprietary Names

MML Specimen Collection Swab

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LIO	Device, Specimen Collection	Microbiology	Class 1	866.2900	2019-06-05
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2021-05-14
NNK	Container, Specimen Mailer And Storage, Non-Sterile	Pathology	Class 1	864.3250	2015-05-11
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2018-11-06
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2019-06-05
JSM	Culture Media, Non-Propagating Transport	Microbiology	Class 1	866.2390	2022-11-07
KXG	Applicator, Absorbent Tipped, Sterile	General Hospital	Class 1	880.6025	2018-12-13
LIO	Device, Specimen Collection	Microbiology	Class 1	866.2900	2022-11-07
HIO	Sampler, Amniotic Fluid (Amniocentesis Tray)	Obstetrics/Gynecology	Class 1	884.1550	2018-12-13
KOC	Accessories, Blood Circuit, Hemodialysis	Gastroenterology, Urology	Class 2	876.5820	2018-11-06
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2018-11-06

Official Correspondent

Jeff Miller

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

MML Diagnostics Packaging

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K003761	Medical Packaging Corp.	NAT - NUCLEIC ACID TRANSPORT	2001-05-31
K150256	Argentum Medical	SILVERLON BURN CONTACT DRESSINGS	2015-04-30
K112888	Kensey Nash Corporation	MESO WOUND MATRIX	2012-02-10
K040211	Collagen Matrix, Inc.	MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING	2004-02-27
K914894	Microtest	VIRAPURE, CHLAMYPURE AND MYCOPURE	1991-12-18

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-06	B. Braun Medical, Inc.	U	D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.
Z-0038-2025	3M Company Health Care Business 3m Center	U	3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R

Similar Registrations

Registration Number	Establishment Name	Location
3017063217	COPAN Diagnostics, Inc.	Carlsbad, CA, US
3016587486	ARX SCIENCES	Amherst, NY, US
2183744	Isomedix Operations, Inc.	Minneapolis, MN, US
8022032	SOUTHMEDIC, INC.	BARRIE Ontario, CA
3013557562	CBR ENTERPRISE LIMITED	Hong Kong, HK

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3018348. Last updated year: 2026. Please use registration number 3018348 when referencing this establishment in official correspondence.