510(k) K852001
K852001 is an FDA 510(k) premarket notification submitted by Alpkem Corp. for the device "AMY REAGENT". The FDA issued a decision of Substantially Equivalent on June 10, 1985. The device falls under product code JFJ (Catalytic Methods, Amylase), a Class II device regulated under 21 CFR 862.1070. Alpkem Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 10, 1985
- Date Received
- May 7, 1985
- 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