510(k) K854811
K854811 is an FDA 510(k) premarket notification submitted by Beckman Instruments, Inc. for the device "ICS PAB PREALBUMIN REAGENT TEST KIT". The FDA issued a decision of Substantially Equivalent on January 24, 1986. The device falls under product code DDS (Prealbumin, Fitc, Antigen, Antiserum, Control), a Class I device regulated under 21 CFR 866.5060. Beckman Instruments, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 24, 1986
- Date Received
- December 3, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prealbumin, Fitc, Antigen, Antiserum, Control
- Device Class
- Class I
- Regulation Number
- 866.5060
- Review Panel
- IM
- Submission Type