510(k) K002855
K002855 is an FDA 510(k) premarket notification submitted by Biocare Corp. for the device "BIOLYTE 2000 NA+,K+,CL-/LI+ELECTROLYTE ANALYZER". The FDA issued a decision of Substantially Equivalent on October 12, 2000. The device falls under product code JGS (Electrode, Ion Specific, Sodium), a Class II device regulated under 21 CFR 862.1665. Biocare Corp. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 12, 2000
- Date Received
- September 13, 2000
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrode, Ion Specific, Sodium
- Device Class
- Class II
- Regulation Number
- 862.1665
- Review Panel
- CH
- Submission Type