ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM— 510(k) K992399
Substantially EquivalentBayer Corp.
FDA 510(k) clearance K992399 for ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM, Substantially Equivalent on 1999-09-15. Applicant: Bayer Corp.. Device class: 2.
Clearance details
- Applicant
- Bayer Corp.
- Product code
- Code CIX
- Device class
- Class 2
- Regulation
- 21 CFR 862.1035
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tarrytown, NY, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.