510(k) K870035
K870035 is an FDA 510(k) premarket notification submitted by Eastman Kodak Company for the device "KODAK EKTACHEM DT SLIDES (CA)". The FDA issued a decision of Substantially Equivalent on May 12, 1987. The device falls under product code CID (Alizarin Sulfonate, Calcium), a Class II device regulated under 21 CFR 862.1145. Eastman Kodak Company has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 12, 1987
- Date Received
- January 5, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Alizarin Sulfonate, Calcium
- Device Class
- Class II
- Regulation Number
- 862.1145
- Review Panel
- CH
- Submission Type