Recognition List Number: 028 Publication Date: 03/16/2012
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 7-166: CLSI GP20-A2, Fine Needle Aspiration Biopsy (FNAB) Techniques; Approved Guideline - Second Edition. (InVitro Diagnostics)
Date of Standard: 2003. |
| 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) |
|
|
| Devices Affected: |
| Cytocentrifuge; Microscopes and accessories; Slides, microscope; Tissue processing equipment |
|
| Processes Affected: |
| Collection and preparation of fine needle aspiration specimens, 510(k), PMA, PDP, IDE, HDE |
|
| Type of Standard: |
| National, Horizontal |
| Extent of Recognition: |
|
| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §864.1850 |
Stain, Ponceau |
Class 1 |
HZO |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §864.3010 |
Cassettes, Tissue |
Class 1 |
IDZ |
| §864.3010 |
Microtome, Accessories |
Class 1 |
IDL |
| §864.3010 |
Microtome, Rotary |
Class 1 |
IDO |
| §864.3010 |
Slides, Microscope |
Class 1 |
KEW |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §864.3300 |
Cytocentrifuge |
Class 1 |
IFB |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §864.3600 |
Light, Microscope |
Class 1 |
IBJ |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §864.3800 |
Stainer, Tissue, Automated |
Class 1 |
KEY |
| |
|
| Relevant Guidance: |
| There is no relevant guidance developed at this time. |
|
| FDA Technical Contact: |
| Tremel Faison |
| FDA/CDRH/OIVD |
| 10993 New Hampshire Avenue Building 66, Room G458 |
| Silver Spring MD 20993 |
| 301/796-6167 |
| Email: tremel.faison@fda.hhs.gov |
|
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