PTS PANELS CHOL+HDL PANEL TEST STRIPS— 510(k) K071593
Substantially EquivalentPolymer Technology Systems, Inc.
FDA 510(k) clearance K071593 for PTS PANELS CHOL+HDL PANEL TEST STRIPS, Substantially Equivalent on 2007-10-15. Applicant: Polymer Technology Systems, Inc.. Device class: 1.
Clearance details
- Applicant
- Polymer Technology Systems, Inc.
- Product code
- Code CHH
- Device class
- Class 1
- Regulation
- 21 CFR 862.1175
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Indianapolis, IN, US
Recent devices under product code CHH
view allMore clearances from Polymer Technology Systems, Inc.
view all- K151545 — CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System, CardioChek PA Home Test System
- K151530 — CardioChek Plus Test System
- K140068 — CARDIOCHEK PLUS TEST SYSTEM, CARDIOCHEK HOME TEST SYSTEM
- K142302 — BioScanner Plus Glucose Test System, PTS PANELS Chol+Glu Test Panel System, PTS PANELS Lipid Panel Test System, PTS PANELS HDL Cholesterol Test System, PTS PANELS CHOL+HDL Test System, PTS PANELS CHOL+HDL+GLU Panel Test System, PTS PANELS Metabolic Chemistry Panel Test System
- K071507 — PTS PANELS CHOL+HDL+GLU PANEL TEST STRIPS
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