510(k) K940682
- Device
- Axsym(tm) Quinidine
- Applicant
- ABBOTT LABORATORIES
- 510(k) number
- K940682
- Product code
- LGI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1994-06-21
- Date received
- 1994-02-10
- Regulation
- 862.3645
- Classification name
- Fluorescence Polarization Immunoassay, Carbamazepine
- Medical specialty
- Clinical Toxicology
- Review panel
- Clinical Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- KATHY ZENG
- Address
- Dept: 09v8 Bldg: Ap5-2 100 Abbott Park Rd. Abbott Park IL US 60064 60064
FDA Registration Numbers#
- 3006198300
- 3003795116
- 9610126
- 9610529