510(k) K003158
K003158 is an FDA 510(k) premarket notification submitted by Roche Diagnostics Corp. for the device "ROCHE DIAGNOSTICS CK-MB". The FDA issued a decision of Substantially Equivalent on December 18, 2000. The device falls under product code JHW (U.V. Method, Cpk Isoenzymes), a Class II device regulated under 21 CFR 862.1215. Roche Diagnostics Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 18, 2000
- Date Received
- October 10, 2000
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- U.V. Method, Cpk Isoenzymes
- Device Class
- Class II
- Regulation Number
- 862.1215
- Review Panel
- CH
- Submission Type