510(k) K982328
K982328 is an FDA 510(k) premarket notification submitted by Bayer Corp. for the device "BAYER ADVIA IMS SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)". The FDA issued a decision of Substantially Equivalent on January 29, 1999. The device falls under product code CJO (Alpha-Naphthyl Phosphate, Alkaline Phosphatase Or Isoenzymes), a Class II device regulated under 21 CFR 862.1050. Bayer Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 29, 1999
- Date Received
- July 2, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Alpha-Naphthyl Phosphate, Alkaline Phosphatase Or Isoenzymes
- Device Class
- Class II
- Regulation Number
- 862.1050
- Review Panel
- CH
- Submission Type