FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MRSASELECT - EXTENDED INCUBATION
K Number: K081212
·
Decision Jun 13, 2008
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
39
Applicant Total
319
Review Days
45
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Basic Information
- Device Name
- MRSASELECT - EXTENDED INCUBATION
- K Number
- K081212
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.1700
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bio-Rad
- Date Received
- April 29, 2008
- Decision Date
- June 13, 2008
- Product Code
- JSO
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JSO | Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar | FDA class 2 | Microbiology |
Similar 510(k) Clearances
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Other Clearances by Bio-Rad
| K Number | Device Name | ||
|---|---|---|---|
| K171061 | MRSASelect II | Dec 28, 2017 | Substantially Equivalent |
| K122187 | VRESELECT CULTURE MEDIUM | Nov 6, 2012 | Substantially Equivalent |
| K103684 | VRESELECT CULTURE MEDIUM | Oct 21, 2011 | Substantially Equivalent |
| K093678 | PLATELIA ASPERGILLUS EIA MODEL 62793 | Jan 13, 2011 | Substantially Equivalent |
| K100589 | MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENS | Oct 29, 2010 | Substantially Equivalent |
| K081362 | PLATELIA LYME IGM | Jun 26, 2008 | Substantially Equivalent |
| K080012 | PLATELIA LYME IGG ASSAY | May 8, 2008 | Substantially Equivalent |
| K070361 | MRSASELECT | Sep 13, 2007 | Substantially Equivalent |
| K060641 | PLATELIA ASPERGILLUS EIA, MODEL 62793 | Jun 2, 2006 | Substantially Equivalent |
| K052838 | LIQUICHEK DIABETES CONTROL, LEVEL 1,2,3,4 | Nov 9, 2005 | Substantially Equivalent |