510(k) K013173
K013173 is an FDA 510(k) premarket notification submitted by Polymer Technology Systems, Inc. for the device "BIOSCANNER PLUS; LIPID PANEL TEST STRIPS". The FDA issued a decision of Substantially Equivalent on October 22, 2001. The device falls under product code CHH (Enzymatic Esterase--Oxidase, Cholesterol), a Class I device regulated under 21 CFR 862.1175. Polymer Technology Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 22, 2001
- Date Received
- September 24, 2001
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Enzymatic Esterase--Oxidase, Cholesterol
- Device Class
- Class I
- Regulation Number
- 862.1175
- Review Panel
- CH
- Submission Type