510(k) K983469
K983469 is an FDA 510(k) premarket notification submitted by Boehringer Mannheim Corp. for the device "PRECISET SERUM PROTEINS CALIBRATOR". The FDA issued a decision of Substantially Equivalent on November 25, 1998. The device falls under product code JIX (Calibrator, Multi-Analyte Mixture), a Class II device regulated under 21 CFR 862.1150. Boehringer Mannheim Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 25, 1998
- Date Received
- October 1, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Calibrator, Multi-Analyte Mixture
- Device Class
- Class II
- Regulation Number
- 862.1150
- Review Panel
- CH
- Submission Type