ADVIA IMS CARBAMAZEPINE METHOD— 510(k) K042808
Substantially EquivalentBayer Healthcare, LLC
FDA 510(k) clearance K042808 for ADVIA IMS CARBAMAZEPINE METHOD, Substantially Equivalent on 2005-02-08. Applicant: Bayer Healthcare, LLC. Device class: 2.
Clearance details
- Applicant
- Bayer Healthcare, LLC
- Product code
- Code KLT
- Device class
- Class 2
- Regulation
- 21 CFR 862.3645
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tarrytown, NY, US
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