510(k) K953211
K953211 is an FDA 510(k) premarket notification submitted by Randox Laboratories, Ltd. for the device "AMYLASE (ETHYLIDENE PNGPG7) KIT". The FDA issued a decision of Substantially Equivalent on June 21, 1996. The device falls under product code CIJ (Saccharogenic, Amylase), a Class II device regulated under 21 CFR 862.1070. Randox Laboratories, Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 21, 1996
- Date Received
- July 10, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Saccharogenic, Amylase
- Device Class
- Class II
- Regulation Number
- 862.1070
- Review Panel
- CH
- Submission Type