510(k) K801096
K801096 is an FDA 510(k) premarket notification submitted by Stat Engineering for the device "PERKIN ELMER MODEL 91 AMYLASE REAGENT". The FDA issued a decision of Substantially Equivalent on June 9, 1980. The device falls under product code KHM (Nephelometric, Amylase), a Class II device regulated under 21 CFR 862.1070.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 9, 1980
- Date Received
- May 9, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Nephelometric, Amylase
- Device Class
- Class II
- Regulation Number
- 862.1070
- Review Panel
- CH
- Submission Type