COMBITROL TS MULTI ANALYTE CONTROL, LEVELS 1,2,3, AUTOTROL TS MULTI ANALYTE CONTROL, LEVELS 1,2,3— 510(k) K012431
Substantially EquivalentBionostics, Inc.
FDA 510(k) clearance K012431 for COMBITROL TS MULTI ANALYTE CONTROL, LEVELS 1,2,3, AUTOTROL TS MULTI ANALYTE CONTROL, LEVELS 1,2,3, Substantially Equivalent on 2001-08-28. Applicant: Bionostics, Inc.. Device class: 1.
Clearance details
- Applicant
- Bionostics, Inc.
- Product code
- Code JJY
- Device class
- Class 1
- Regulation
- 21 CFR 862.1660
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Acton, MA, US
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