Recognition List Number: 020 Publication Date: 09/09/2008
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 7-163: CLSI H56-A, Body Fluid Analysis for Cellular Composition. (InVitro Diagnostics)
Date of Standard: 2005. |
| Address of Standards Organization: |
| Clinical Laboratory Standards Institute (CLSI) |
| 950 West Valley Road |
| Suite 2500 |
| Wayne, PA 19087 |
| |
|
| CDRH Office and Division Associated with Recognized Standards: |
| OFFICE OF IN VITRO DIAGNOSTICS AND RADIOLOGICAL HEALTH (OIR) | | DIVISION OF IMMUNOLOGY AND HEMATOLOGY DEVICES (DIHD) |
|
|
| Devices Affected: |
| Automated Cell Counters, Automated Differential Cell Counters |
|
| Processes Affected: |
|
| Type of Standard: |
| National, Horizontal |
| Extent of Recognition: |
|
| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §864.5200 |
Counter, Cell, Automated (Particle Counter) |
Class 2 |
GKL |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §864.5220 |
Counter, Differential Cell |
Class 2 |
GKZ |
| |
|
| Relevant Guidance: |
| Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells |
|
| FDA Technical Contact: |
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