510(k) K802080
K802080 is an FDA 510(k) premarket notification submitted by J.T. Baker Chemical Co. for the device "BAKER DIAG. ULTRARATE CHLORIDE KIT". The FDA issued a decision of Substantially Equivalent on October 10, 1980. The device falls under product code JFS (Coulometric, Chloride), a Class II device regulated under 21 CFR 862.1170. J.T. Baker Chemical Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 10, 1980
- Date Received
- August 28, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Coulometric, Chloride
- Device Class
- Class II
- Regulation Number
- 862.1170
- Review Panel
- CH
- Submission Type