AIMSTICK URINE REAGENT STRIPS
FDA 510(k) clearance K051727 · decided 2005-10-26
Clearance details
- K-number
- K051727
- Device name
- AIMSTICK URINE REAGENT STRIPS
- Applicant
- Germaine Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-06-28
- Decision date
- 2005-10-26
- Days to decision
- 120 days
- Clearance type
- Traditional
- Product code
- CEN
- Device class
- 1
- Regulation number
- 862.1550
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- San Antonio, TX, US
- Third-party review
- No
- Expedited review
- No
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| HELENA BIOSTRIP PH (K830979) | Helena Laboratories | 1983-05-05 |
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Recalls involving this device
No recalls on record reference this clearance.