510(k) K991817
K991817 is an FDA 510(k) premarket notification submitted by Bayer Corp. for the device "ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM". The FDA issued a decision of Substantially Equivalent on July 22, 1999. The device falls under product code CIJ (Saccharogenic, Amylase), a Class II device regulated under 21 CFR 862.1070. Bayer Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 22, 1999
- Date Received
- May 27, 1999
- 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