510(k) K854946
- Device
- Tdxr 5-hiaa (urine)
- Applicant
- ABBOTT LABORATORIES
- 510(k) number
- K854946
- Product code
- CDA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-01-17
- Date received
- 1985-12-10
- Regulation
- 862.1390
- Classification name
- Acid, Nitrous And Nitrosonaphthol, 5-Hydroxyindole Acetic Acid/Serotonin
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- NANCY A HORNBAKER
- Address
- One Abbott Park Rd. Abbott Park IL US 60064 60064
FDA Registration Numbers#
- 3002800697
- 2245285
- 3003951180
Source Documents#
510(k) summary PDF not indicated by FDA