510(k) K000586
K000586 is an FDA 510(k) premarket notification submitted by Polymer Technology Systems, Inc. for the device "BIOSCANNER TRIGLYCERIDES TEST STRIPS". The FDA issued a decision of Substantially Equivalent on July 3, 2000. The device falls under product code JGY (Colorimetric Method, Triglycerides), a Class I device regulated under 21 CFR 862.1705. Polymer Technology Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 3, 2000
- Date Received
- February 22, 2000
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Colorimetric Method, Triglycerides
- Device Class
- Class I
- Regulation Number
- 862.1705
- Review Panel
- CH
- Submission Type