STERICHEK CHLORINE REAGENT STRIPS
FDA 510(k) clearance K971598 · decided 1997-07-18
Clearance details
- K-number
- K971598
- Device name
- STERICHEK CHLORINE REAGENT STRIPS
- Applicant
- Environmental Test Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-05-01
- Decision date
- 1997-07-18
- Days to decision
- 78 days
- Clearance type
- Traditional
- Product code
- MSY
- Device class
- 2
- Regulation number
- 876.5665
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Elkhart, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.