510(k) K103037
- Device
- IND URINARY TRACT INFECTION (UTI) TEST STRIPS
- Applicant
- IND DIAGNOSTIC, INC.
- 510(k) number
- K103037
- Product code
- NGJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2012-04-17
- Date received
- 2010-10-14
- Regulation
- 862.1510
- Classification name
- Test, Nitrite, Urinary, Non-quantitative, Over The Counter
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- KAI LOU
- Address
- 1629 Fosters Way Delta, B.C. CA V3M 6S7 V3M 6S7
FDA Registration Numbers#
- 1649661
- 2531491
- 9615507
- 3003917514
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Decision Summary