510(k) K802376
K802376 is an FDA 510(k) premarket notification submitted by Eastman Kodak Company for the device "KODAK EKTA-CHEM CLINICAL CHEM. SLIDES". The FDA issued a decision of Substantially Equivalent on October 23, 1980. The device falls under product code CHS (Coulometric Method, Carbon-Dioxide), a Class II device regulated under 21 CFR 862.1160. Eastman Kodak Company has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 23, 1980
- Date Received
- September 30, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Coulometric Method, Carbon-Dioxide
- Device Class
- Class II
- Regulation Number
- 862.1160
- Review Panel
- CH
- Submission Type