FIRST CHOICE GLUCOSE URINE TEST STRIPS
FDA 510(k) clearance K953661 · decided 1996-06-14
Clearance details
- K-number
- K953661
- Device name
- FIRST CHOICE GLUCOSE URINE TEST STRIPS
- Applicant
- Polymer Technology Intl.
- Decision
- Substantially Equivalent
- Date received
- 1995-08-07
- Decision date
- 1996-06-14
- Days to decision
- 312 days
- Clearance type
- Traditional
- Product code
- JIL
- Device class
- 2
- Regulation number
- 862.1340
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Issaquah, WA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.