Recognition List Number: 009 Publication Date: 03/08/2004
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 7-86: NCCLS C29-A2, Standardization of Sodium and Potassium Ion Selective Electrode Systems to the Flame Photometric Reference Method; Approved Standard (2000) ISBN 1-56238-406-6. (InVitro Diagnostics)
Date of Standard: 2000. |
| Address of Standards Organization: |
| National Committee for Clinical Laboratory Standards (NCCLS) |
| 950 West Valley Road |
| Suite 2500 |
| Wayne, PA 19087 |
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| CDRH Offices and Divisions Associated with Recognized Standards: |
| (1) | OFFICE OF IN VITRO DIAGNOSTICS AND RADIOLOGICAL HEALTH (OIR) | | DIVISION OF CHEMISTRY AND TOXICOLOGY DEVICES (DCTD) |
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| (2) | OFFICE OF COMPLIANCE (OC) |
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| Devices Affected: |
| In Vitro Diagnostic devices for the measurement of sodium and potassium using ion-selective electrodes system |
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| Processes Affected: |
| 510(K), PMA, PDP, IDE, HDE |
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| Type of Standard: |
| National, Horizontal |
| Extent of Recognition: |
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| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §862.1600 |
Electrode, Ion Specific, Potassium |
Class 2 |
CEM |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §862.1665 |
Electrode, Ion Specific, Sodium |
Class 2 |
JGS |
| |
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| Relevant Guidance: |
| Points to Consider for Consider for Collection of Data in Support of In-Vitro Device Submissions for 510(k) Clearance Guidance for Industry In Vitro Diagnostic Potassium Test System Guidance for Industry In Vitro Diagnostic Sodium Test System. |
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| FDA Technical Contact: |
| Carol C. Benson |
| FDA/CDRH/OIVD |
| 2098 GAITHER ROAD, HFZ-440 |
| ROCKVILLE MD 20850 |
| 240/276-0396 |
| Email: carol.benson@fda.hhs.gov |
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