510(k) K791826
K791826 is an FDA 510(k) premarket notification submitted by Clinical Sciences, Inc. for the device "CPK CLINI GEL KIT". The FDA issued a decision of Substantially Equivalent on October 1, 1979. The device falls under product code JHT (Chromatographic Separation, Cpk Isoenzymes), a Class II device regulated under 21 CFR 862.1215. Clinical Sciences, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 1, 1979
- Date Received
- September 17, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Chromatographic Separation, Cpk Isoenzymes
- Device Class
- Class II
- Regulation Number
- 862.1215
- Review Panel
- CH
- Submission Type