MTM BIOSCANNER HDL TEST STRIPS, OVER THE COUNTER (OTC)— 510(k) K993377
Substantially EquivalentPolymer Technology Systems, Inc.
FDA 510(k) clearance K993377 for MTM BIOSCANNER HDL TEST STRIPS, OVER THE COUNTER (OTC), Substantially Equivalent on 2000-01-13. Applicant: Polymer Technology Systems, Inc.. Device class: 1.
Clearance details
- Applicant
- Polymer Technology Systems, Inc.
- Product code
- Code NAQ
- Device class
- Class 1
- Regulation
- 21 CFR 862.1175
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Indianapolis, IN, US
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- K071593 — PTS PANELS CHOL+HDL PANEL TEST STRIPS
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