ROCHE COMBITROL AND AUTOTROL PLUS B MULTI ANALYTE CONTROL— 510(k) K032453
Substantially EquivalentBionostics, Inc.
FDA 510(k) clearance K032453 for ROCHE COMBITROL AND AUTOTROL PLUS B MULTI ANALYTE CONTROL, Substantially Equivalent on 2003-08-28. 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
- Devens, MA, US
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