Advia 120 Hematology System, Cerebrospinal Fluid Method
FDA 510(k) K022331 · Bayer Diagnostics Corp.
510(k) numberK022331
Submission
- Device name
- Advia 120 Hematology System, Cerebrospinal Fluid Method
- Applicant
- Bayer Diagnostics Corp.
Tarrytown, NY, US - Received
- July 18, 2002
- Decision date
- September 11, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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| K032677 | Sysmex POCH-100IGKL · Traditional | Sysmex America, Inc. | 02/11/2004SE |
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| K023840 | Acid Phosphatase Assay for the Advia 1650CKB · Traditional | 01/07/2003SE |
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Questions and answers
When was Advia 120 Hematology System, Cerebrospinal Fluid Method cleared by the FDA?
Advia 120 Hematology System, Cerebrospinal Fluid Method (K022331) received a 510(k) decision of Substantially Equivalent on September 11, 2002, 55 days after the submission was received.
What is the product code of K022331?
The FDA product code is GKL – Counter, Cell, Automated (Particle Counter), a Class II (moderate risk) device regulated under 21 CFR 864.5200.