510(k) K821869
K821869 is an FDA 510(k) premarket notification submitted by Harleco Diagnostics for the device "ULTRAZYME PLUS AMYL". The FDA issued a decision of Substantially Equivalent on July 13, 1982. The device falls under product code JFJ (Catalytic Methods, Amylase), a Class II device regulated under 21 CFR 862.1070. Harleco Diagnostics has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 13, 1982
- Date Received
- June 25, 1982
- 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