510(k) K031902
- Device
- ONLINE TDM CARBAMAZEPINE
- Applicant
- ROCHE DIAGNOSTICS CORP.
- 510(k) number
- K031902
- Product code
- KLT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-09-17
- Date received
- 2003-06-20
- Regulation
- 862.3645
- Classification name
- Enzyme Immunoassay, Carbamazepine
- Medical specialty
- Toxicology
- Review panel
- Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- KERWIN KAUFMAN
- Address
- 9115 Hague Rd. Indianapolis IN US 46250 46250
FDA Registration Numbers#
- 3010939897
- 2517506
- 3005333358
- 3006198300
- 3002806944
- 3004493545
- 3000308930
- 3002809144
- 3010825766
- 3002642396
- 9610126
- 1319809
- 1036362
- 1181121
- 3012963943
- 2250051
- 2050012
- 2050010
- 2432235
- 1319681
Source Documents#
Legacy Summary#
summary
FDA Review#
Decision Summary