510(k) K873250
K873250 is an FDA 510(k) premarket notification submitted by Roche Diagnostic Systems, Inc. for the device "ISOMUNE-AMYLASE AND ISOMUNE-AMYLASE CONTROL". The FDA issued a decision of Substantially Equivalent on October 20, 1987. The device falls under product code CIJ (Saccharogenic, Amylase), a Class II device regulated under 21 CFR 862.1070. Roche Diagnostic Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 20, 1987
- Date Received
- August 17, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Saccharogenic, Amylase
- Device Class
- Class II
- Regulation Number
- 862.1070
- Review Panel
- CH
- Submission Type