510(k) K070064
K070064 is an FDA 510(k) premarket notification submitted by Thermo Fisher Scientific for the device "AMYLASE EPS REAGENT". The FDA issued a decision of Substantially Equivalent on May 22, 2007. The device falls under product code JFJ (Catalytic Methods, Amylase), a Class II device regulated under 21 CFR 862.1070. Thermo Fisher Scientific has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 22, 2007
- Date Received
- January 5, 2007
- 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