510(k) K103037
K103037 is an FDA 510(k) premarket notification submitted by Ind Diagnostic, Inc. for the device "IND URINARY TRACT INFECTION (UTI) TEST STRIPS". The FDA issued a decision of Substantially Equivalent on April 17, 2012. The device falls under product code NGJ (Test, Nitrite, Urinary, Non-Quantitative, Over The Counter), a Class I device regulated under 21 CFR 862.1510. Ind Diagnostic, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 17, 2012
- Date Received
- October 14, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Test, Nitrite, Urinary, Non-Quantitative, Over The Counter
- Device Class
- Class I
- Regulation Number
- 862.1510
- Review Panel
- TX
- Submission Type