510(k) K852556
- Device
- Tdx Rea Triglycerides
- Applicant
- ABBOTT LABORATORIES
- 510(k) number
- K852556
- Product code
- JGW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-07-22
- Date received
- 1985-06-17
- Regulation
- 862.1705
- Classification name
- Fluorometric Method, Triglycerides
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- MARY E ZORC
- Address
- One Abbott Park Rd. Abbott Park IL US 60064 60064
FDA Registration Numbers#
- 3017379203
Source Documents#
510(k) summary PDF not indicated by FDA