GLUTARTEST 1 REAGENT STRIP— 510(k) K002011
Substantially EquivalentIntegrated Biomedical Technology, Inc.
FDA 510(k) clearance K002011 for GLUTARTEST 1 REAGENT STRIP, Substantially Equivalent on 2001-01-22. Applicant: Integrated Biomedical Technology, Inc.. Device class: 2.
Clearance details
- Applicant
- Integrated Biomedical Technology, Inc.
- Product code
- Code MSY
- Device class
- Class 2
- Regulation
- 21 CFR 876.5665
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Elkhart, IN, US
Recent devices under product code MSY
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