FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PLATELIA ASPERGILLUS EIA MODEL 62793
K Number: K093678
·
Decision Jan 13, 2011
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
3
Applicant Total
319
Review Days
412
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- PLATELIA ASPERGILLUS EIA MODEL 62793
- K Number
- K093678
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3040
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bio-Rad
- Date Received
- November 27, 2009
- Decision Date
- January 13, 2011
- Product Code
- NOM
- 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 |
|---|---|---|---|
| NOM | Antigen, Galactomannan, Aspergillus Spp. | FDA class 1 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NOM), ordered by most recent decision date.
MycoMEIA Aspergillus Assay
FDA 510(k)
FDA Class 1
·Microbiology
PLATELIA ASPERGILLUS EIA, MODEL 62793
FDA 510(k)
FDA Class 1
·Microbiology
PLATELIA ASPERGILLUS EIA, MODELS 62793 AND 62794
FDA 510(k)
FDA Class 1
·Microbiology
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 |
| K100589 | MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENS | Oct 29, 2010 | Substantially Equivalent |
| K081362 | PLATELIA LYME IGM | Jun 26, 2008 | Substantially Equivalent |
| K081212 | MRSASELECT - EXTENDED INCUBATION | Jun 13, 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 |