GLUTARTEST 1 REAGENT STRIP
FDA 510(k) clearance K002011 · decided 2001-01-22
Clearance details
- K-number
- K002011
- Device name
- GLUTARTEST 1 REAGENT STRIP
- Applicant
- Integrated Biomedical Technology, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2000-07-03
- Decision date
- 2001-01-22
- Days to decision
- 203 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.