FDA 510(k)
FDA class 1
Substantially Equivalent
🇨🇦 Canada
IND URINARY TRACT INFECTION (UTI) TEST STRIPS
K Number: K103037
·
Decision Apr 17, 2012
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
0
Applicant Total
8
Review Days
551
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- IND URINARY TRACT INFECTION (UTI) TEST STRIPS
- K Number
- K103037
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1510
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Ind Diagnostic, Inc.
- Date Received
- October 14, 2010
- Decision Date
- April 17, 2012
- Product Code
- NGJ
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NGJ | Test, Nitrite, Urinary, Non-Quantitative, Over The Counter | FDA class 1 | Clinical Chemistry |
Other Clearances by Ind Diagnostic, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K100031 | IND ONE STEP FECAL OCCULT BLOOD TEST MODEL 440-10 | Jul 19, 2010 | Substantially Equivalent |
| K063390 | URINE CHEMISTRY ANALYZER UR-50 | Mar 1, 2007 | Substantially Equivalent |
| K060810 | ONE STEP DRUG TEST - AMP/MET/MOR/THC/COC | Aug 7, 2006 | Substantially Equivalent |
| K052694 | ONE STEP HCG PREGNANCY TEST - 2000 MIU/ML, MODEL 100 SERIES. | Dec 16, 2005 | Substantially Equivalent |
| K052662 | ONE STEP FSH MENOPAUSAL TEST | Nov 30, 2005 | Substantially Equivalent |
| K050741 | IND ONE STEP HCG PREGNANCY TEST - CASSETTE FORMAT | May 16, 2005 | Substantially Equivalent |
| K023638 | CASSETTE/URINE HCG | Jan 3, 2003 | Substantially Equivalent |