510(k) K914510
K914510 is an FDA 510(k) premarket notification submitted by Beckman Instruments, Inc. for the device "CALCIUM/LITHIUM TEST BECKMAN SYNCHRON EL-ISE ANALY". The FDA issued a decision of Substantially Equivalent on November 19, 1991. The device falls under product code JFN (Atomic Absorption, Calcium), a Class II device regulated under 21 CFR 862.1145. Beckman Instruments, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 19, 1991
- Date Received
- October 9, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Atomic Absorption, Calcium
- Device Class
- Class II
- Regulation Number
- 862.1145
- Review Panel
- CH
- Submission Type