510(k) K780886
- Device
- System 6000 Automated Ria Analyzer
- Applicant
- BECKMAN INSTRUMENTS, INC.
- 510(k) number
- K780886
- Product code
- LCI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1978-09-01
- Date received
- 1978-05-26
- Regulation
- 862.2050
- Classification name
- Automated Radioimmunoassay Systems, For Clinical Use
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
Source Documents#
510(k) summary PDF not indicated by FDA