Modification to Bayer Advia 2120 Hematology Analyzer with Autoslide System
FDA 510(k) K051693 · Bayer Healthcare, LLC
510(k) numberK051693
Submission
- Device name
- Modification to Bayer Advia 2120 Hematology Analyzer with Autoslide System
- Applicant
- Bayer Healthcare, LLC
Tarrytown, NY, US - Received
- June 23, 2005
- Decision date
- December 7, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GKL – Counter, Cell, Automated (Particle Counter)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.5200
- Specialty
- Hematology
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Questions and answers
When was Modification to Bayer Advia 2120 Hematology Analyzer with Autoslide System cleared by the FDA?
Modification to Bayer Advia 2120 Hematology Analyzer with Autoslide System (K051693) received a 510(k) decision of Substantially Equivalent on December 7, 2005, 167 days after the submission was received.
What is the product code of K051693?
The FDA product code is GKL – Counter, Cell, Automated (Particle Counter), a Class II (moderate risk) device regulated under 21 CFR 864.5200.