510(k) K894081
K894081 is an FDA 510(k) premarket notification submitted by Roche Diagnostic Systems, Inc. for the device "ROCHO ISOMUNE - LD". The FDA issued a decision of Substantially Equivalent on August 31, 1989. The device falls under product code CFE (Electrophoretic, Lactate Dehydrogenase Isoenzymes), a Class II device regulated under 21 CFR 862.1445. Roche Diagnostic Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 31, 1989
- Date Received
- June 8, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrophoretic, Lactate Dehydrogenase Isoenzymes
- Device Class
- Class II
- Regulation Number
- 862.1445
- Review Panel
- CH
- Submission Type