STAT-TRAK PLUS LIQUID CHEMISTRY CONTROLS 1,2 & 3— 510(k) K843986
Substantially EquivalentUnited Diagnostics, Inc.
FDA 510(k) clearance K843986 for STAT-TRAK PLUS LIQUID CHEMISTRY CONTROLS 1,2 & 3, Substantially Equivalent on 1984-11-27. Applicant: United Diagnostics, Inc.. Device class: 1.
Clearance details
- Applicant
- United Diagnostics, 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
- Natick, MA, US
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