510(k) K770948
- Device
- LIPOPROTEIN PROFILING SYSTEM
- Applicant
- Beckman Instruments, Inc.
- 510(k) number
- K770948
- Product code
- JHL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-07-15
- Date received
- 1977-05-25
- Regulation
- 862.1475
- Classification name
- Microdensitometry Method, Lipoproteins
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- N
Related Records
Applicant Contact
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
Source Documents
510(k) summary PDF not indicated by FDA