510(k) K761100
- Device
- MULTI-CELL ULTRAFILTRATION SYSTEM
- Applicant
- Amicon, Inc.
- 510(k) number
- K761100
- Product code
- JQQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1976-12-06
- Date received
- 1976-11-23
- Regulation
- 862.2050
- Classification name
- Dialyzer
- 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