510(k) K812447
K812447 is an FDA 510(k) premarket notification submitted by Bioscientific for the device "AMYLASE REAGENT KIT". The FDA issued a decision of Substantially Equivalent on September 9, 1981. The device falls under product code KHM (Nephelometric, Amylase), a Class II device regulated under 21 CFR 862.1070. Bioscientific has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 9, 1981
- Date Received
- August 28, 1981
- 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