PTS PANELS MULTI-CHEMISTRY CONTROLS— 510(k) K022401
Substantially EquivalentPolymer Technology Systems, Inc.
FDA 510(k) clearance K022401 for PTS PANELS MULTI-CHEMISTRY CONTROLS, Substantially Equivalent on 2002-08-21. Applicant: Polymer Technology Systems, Inc.. Device class: 1.
Clearance details
- Applicant
- Polymer Technology Systems, 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
- Indianapolis, IN, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.