BIOSCANNER TRIGLYCERIDES TEST STRIPS— 510(k) K991894
Substantially EquivalentPolymer Technology Systems, Inc.
FDA 510(k) clearance K991894 for BIOSCANNER TRIGLYCERIDES TEST STRIPS, Substantially Equivalent on 2000-05-24. Applicant: Polymer Technology Systems, Inc.. Device class: 1.
Clearance details
- Applicant
- Polymer Technology Systems, Inc.
- Product code
- Code JGY
- Device class
- Class 1
- Regulation
- 21 CFR 862.1705
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Indianapolis, IN, US
Recent devices under product code JGY
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- K071593 — PTS PANELS CHOL+HDL PANEL TEST STRIPS
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