FIRST CHOICE GLUCOSE & KETONES URINE TEST STRIPS— 510(k) K953680
Substantially EquivalentPolymer Technology Intl.
FDA 510(k) clearance K953680 for FIRST CHOICE GLUCOSE & KETONES URINE TEST STRIPS, Substantially Equivalent on 1996-06-12. Applicant: Polymer Technology Intl.. Device class: 1.
Clearance details
- Applicant
- Polymer Technology Intl.
- 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
- Issaquah, WA, US
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