Recognition List Number: 030 Publication Date: 01/15/2013
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 14-362: AOAC 6.2.01:2012, Official Method 955.14, Testing Disinfectants Against Salmonella choleraesuis, Use-Dilution Method. (Sterility)
Date of Standard: 2012. |
| Address of Standards Organization: |
| AOAC International (AOAC) |
| 481 North Frederick Avenue |
| Suite 500 |
| Gaithersburg, MD 20877-2417 |
| |
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| CDRH Offices and Divisions Associated with Recognized Standards: |
| (1) | OFFICE OF DEVICE EVALUATION (ODE) | | |
|
| (2) | OFFICE OF COMPLIANCE (OC) | | |
|
| (3) | OFFICE OF SURVEILLANCE AND BIOMETRICS (OSB) |
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| Devices Affected: |
| Liquid chemical sterilants (high level disinfectants), general purpose disinfectants |
|
| Processes Affected: |
| 510(k), PMA, PDP, IDE, HDE, Design Control Input, Quality System Regulation |
|
| Type of Standard: |
| National, Vertical |
| Extent of Recognition: |
| Complete standard and any annexes |
|
| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §880.6885 |
Sterilant, Medical Devices |
Class 2 |
MED |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §880.6890 |
Disinfectant, Medical Devices |
Class 1 |
LRJ |
| |
|
| Relevant Guidance: |
Content and Format of Premarket Notification [510(k)] Submissions for Liquid Chemical Sterilants/High Level Disinfectants, January 3, 2000
ANSI/AAMI ST58:2005/(R2010), Chemical sterilization and high-level disinfection in health care faclilities. |
|
| FDA Technical Contacts: |
| Myra Smith |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room 2456 |
| Silver Spring MD 20993 |
| 301/796-6507 |
| Email: myra.smith@fda.hhs.gov |
|
| Geetha C. Jayan, M.V.Sc, Ph.D |
| FDA/CDRH/OCD |
| 10903 New Hampshire Avenue Building 66, Room 5400 |
| Silver Spring MD 20993 |
| 301/796-6300 |
| Email: geetha.jayan@fda.hhs.gov |
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