FDA Registration Active 🇺🇸 United States

Abbott SF Single Use Lancing Device

Reg #: 2954323 · FEI: 3002803444 · Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1

Registration Details

Registration Name
ABBOTT DIABETES CARE INC.
Registration Number
2954323
FEI Number
3002803444
Status
Active
Expiry Year
2025
Initial Importer
Yes
Address
1360 SOUTH LOOP RD.
City
ALAMEDA
State
CA
ZIP
94502
Country
US

Regulatory Submissions

510(k) Number
K221126

Owner / Operator

Firm Name
ABBOTT LABORATORIES
Operator Number
1415939
Address
100 ABBOTT PARK RD., D-03Q3, AP52-1
City
Abbott Park
State
IL
Postal Code
60064
Country
US

Products

Device Name Product Code
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature FMK

Proprietary Names

Abbott SF Single Use Lancing Device

Establishment Types

Complaint File Establishment per 21 CFR 820.198