Recognition List Number: 023 Publication Date: 05/05/2010
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 7-209: CLSI POCT 05-A, Performance Metrics for Continuous Interstitial Glucose Monitoring. (InVitro Diagnostics)
Date of Standard: 2008. |
| 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: |
|
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| Devices Affected: |
| Continuous Glucose Monitoring Systems |
|
| Processes Affected: |
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| Type of Standard: |
| National, Vertical |
| Extent of Recognition: |
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| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| Unclassified |
Sensor, Glucose, Invasive |
Class 3 |
MDS |
| |
|
| Relevant Guidance: |
| There is no relevant guidance developed at this time. |
|
| FDA Technical Contact: |
| Patricia Bernhardt |
| FDA/CDRH/OIVD |
| 10903 New Hampshire Avenue Building 66, Room 5654 |
| Silver Spring MD 20993 |
| 301/796-6136 |
| Email: patricia.bernhardt@fda.hhs.gov |
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