STERICHEK SENSITIVE-FEED WATER AND RINSE WATER REAGENT STRIPS
FDA 510(k) clearance K003615 · decided 2001-02-01
Clearance details
- K-number
- K003615
- Device name
- STERICHEK SENSITIVE-FEED WATER AND RINSE WATER REAGENT STRIPS
- Applicant
- Environmental Test Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2000-11-22
- Decision date
- 2001-02-01
- Days to decision
- 71 days
- Clearance type
- Special
- Product code
- FKP
- Device class
- 2
- Regulation number
- 876.5820
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Elkhart, IN, US
- Third-party review
- No
- Expedited review
- No
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