Recognition List Number: 020 Publication Date: 09/09/2008
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 7-137: CLSI LA4-A5, Blood Collection on Filter Paper for Newborn Screening Programs. (InVitro Diagnostics)
Date of Standard: 2007. |
| 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: |
| Blood collection on filter paper for neonatal screening |
|
| Processes Affected: |
| 510(K), PMA, PDP, IDE, HDE |
|
| Type of Standard: |
| Horizontal, National |
| Extent of Recognition: |
|
| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §862.1675 |
Tubes, Vials, Systems, Serum Separators, Blood Collection |
Class 2 |
JKA |
| |
|
| Relevant Guidance: |
| Points to Consider for Collection of Data in Support of In Vitro Device Submissions for 510(k) Clearance |
|
| 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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