510(k) K913196
K913196 is an FDA 510(k) premarket notification submitted by Eastman Kodak Company for the device "KODAK EKTACHEM DT SLIDES (LIPASE)". The FDA issued a decision of Substantially Equivalent on September 25, 1991. The device falls under product code CHT (Electrophoretic Method, Catecholamines), a Class I device regulated under 21 CFR 862.1165. Eastman Kodak Company has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 25, 1991
- Date Received
- July 18, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrophoretic Method, Catecholamines
- Device Class
- Class I
- Regulation Number
- 862.1165
- Review Panel
- CH
- Submission Type