510(k) K930678
K930678 is an FDA 510(k) premarket notification submitted by Horizon Diagnostics, Inc. for the device "AMYLASE". The FDA issued a decision of Substantially Equivalent on April 6, 1994. The device falls under product code JFJ (Catalytic Methods, Amylase), a Class II device regulated under 21 CFR 862.1070. Horizon Diagnostics, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 6, 1994
- Date Received
- February 9, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catalytic Methods, Amylase
- Device Class
- Class II
- Regulation Number
- 862.1070
- Review Panel
- CH
- Submission Type