510(k) K854811
- Device
- Ics Pab Prealbumin Reagent Test Kit
- Applicant
- BECKMAN INSTRUMENTS, INC.
- 510(k) number
- K854811
- Product code
- DDS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-01-24
- Date received
- 1985-12-03
- Regulation
- 866.5060
- Classification name
- Prealbumin, Fitc, Antigen, Antiserum, Control
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- JACK E SOROKIN
- Address
- 2500 Harbor Blvd. P.O. Box 3100 Fullerton CA US 92634 92634
FDA Registration Numbers#
- 2050012
- 2517506
- 2050010
- 1836161
- 9680746
- 3003761012
Source Documents#
510(k) summary PDF not indicated by FDA