Recognition List Number: 020 Publication Date: 09/09/2008
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 7-21: CLSI C42-A, Erythrocyte Protoporphyrin Testing; Approved Guideline (1996). (InVitro Diagnostics)
Date of Standard: 1996. |
| 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 DEVICE EVALUATION (ODE) | | |
|
|
| Devices Affected: |
| Erythrocyte protoporphyrin testing |
|
| Processes Affected: |
| 510(k), PMA, PDP, IDE, HDE |
|
| Type of Standard: |
| National, Vertical |
| Extent of Recognition: |
|
| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §862.1595 |
Fluorometric Measurement, Porphyrins |
Class 1 |
JKJ |
| |
|
| Relevant Guidance: |
| Points to Consider for Collection of Data in Support of In Vitro Device Submissions for 510(k) Clearance |
|
| FDA Technical Contact: |
| Arleen Pinkos |
| FDA/CDRH/OIVD |
| 10903 New Hampshire Avenue Building 66, Room 5618 |
| Silver Spring MD 20993 |
| 301/796-6152 |
| Email: arleen.pinkos@fda.hhs.gov |
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