KYOTEST UK URINE TEST REAGENT STRIP— 510(k) K841715
Substantially EquivalentKyoto Diagnostics, Inc.
FDA 510(k) clearance K841715 for KYOTEST UK URINE TEST REAGENT STRIP, Substantially Equivalent on 1984-05-31. Applicant: Kyoto Diagnostics, Inc.. Device class: 1.
Clearance details
- Applicant
- Kyoto Diagnostics, Inc.
- Product code
- Code JIN
- Device class
- Class 1
- Regulation
- 21 CFR 862.1435
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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