510(k) K912580
K912580 is an FDA 510(k) premarket notification submitted by Polymer Technology Corp. for the device "FIRST CHOICE". The FDA issued a decision of Substantially Equivalent on March 4, 1992. The device falls under product code CGA (Glucose Oxidase, Glucose), a Class II device regulated under 21 CFR 862.1345. Polymer Technology Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 4, 1992
- Date Received
- June 12, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Glucose Oxidase, Glucose
- Device Class
- Class II
- Regulation Number
- 862.1345
- Review Panel
- CH
- Submission Type