FDA Registration Active 🇺🇸 United States

R723110 Liquid Stuarts,Single Swab PK/500

Reg #: 1924669 · FEI: 1924669 · Expires 2025
Products
1
Proprietary Names
6
Establishment Types
2
Classifications
1

Registration Details

Registration Name
REMEL, INC.
Registration Number
1924669
FEI Number
1924669
Status
Active
Expiry Year
2025
Initial Importer
Yes
Address
12076 Santa Fe Trail Dr
City
LENEXA
State
KS
ZIP
66215
Country
US

Regulatory Submissions

510(k) Number
K943499

Owner / Operator

Firm Name
Thermo Fisher Scientific
Operator Number
2517925
Address
168 Third Avenue, --
City
Waltham
State
MA
Postal Code
02451
Country
US

Products

Device Name Product Code
Culture Media, Non-Propagating Transport JSM

Proprietary Names

R723110 Liquid Stuarts,Single Swab PK/500 R723125 Liquid Stuarts,Dual Swab PK/50 R723130 Liquid Stuarts,Wire Shaft Swab PK/100 R723135 Liquid Stuarts,Wire Shaft PK/50 R723115 Liquid Stuarts,Single Swab PK/50 R723120 Liquid Stuarts,Dual Swab PK/500

Establishment Types

Repack or Relabel Medical Device Complaint File Establishment per 21 CFR 820.198