KYOTEST UK URINE TEST REAGENT STRIP
FDA 510(k) clearance K841715 · decided 1984-05-31
Clearance details
- K-number
- K841715
- Device name
- KYOTEST UK URINE TEST REAGENT STRIP
- Applicant
- Kyoto Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-04-24
- Decision date
- 1984-05-31
- Days to decision
- 37 days
- Clearance type
- Traditional
- Product code
- JIN
- Device class
- 1
- Regulation number
- 862.1435
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.