FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
BD MAX STAPHSR ASSAY, INSTRUMENT
K Number: K132822
·
Decision Nov 26, 2013
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
23
Applicant Total
4
Review Days
78
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
- BD MAX STAPHSR ASSAY, INSTRUMENT
- K Number
- K132822
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.1640
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Geneohm Sciences Canada, Inc. (Bd Diagnostics)
- Date Received
- September 9, 2013
- Decision Date
- November 26, 2013
- Product Code
- NQX
- 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 |
|---|---|---|---|
| NQX | System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen | FDA class 2 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NQX), ordered by most recent decision date.
Xpert MRSA/SA SSTI
FDA 510(k)
FDA Class 2
·Microbiology
Xpert® SA Nasal Complete
FDA 510(k)
FDA Class 2
·Microbiology
ARIES MRSA Assay
FDA 510(k)
FDA Class 2
·Microbiology
Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 System
FDA 510(k)
FDA Class 2
·Microbiology
Xpert MRSA NxG
FDA 510(k)
FDA Class 2
·Microbiology
cobas MRSA/SA Test
FDA 510(k)
FDA Class 2
·Microbiology