510(k) K840151
K840151 is an FDA 510(k) premarket notification submitted by Eastman Kodak Company for the device "EKTACHEM CLINICAL CHEM. SLIDES". The FDA issued a decision of Substantially Equivalent on March 22, 1984. The device falls under product code CED (5-Amp-Phosphate Release (Colorimetric Test), 5'-Nucleotidase), a Class I device regulated under 21 CFR 862.1520. Eastman Kodak Company has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 22, 1984
- Date Received
- January 13, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- 5-Amp-Phosphate Release (Colorimetric Test), 5'-Nucleotidase
- Device Class
- Class I
- Regulation Number
- 862.1520
- Review Panel
- CH
- Submission Type