FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH CEPHALOTHIN (0.5-32 UG/ML)
K Number: K031601
·
Decision Apr 2, 2004
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
284
Applicant Total
343
Review Days
317
Basic Information
- Device Name
- MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH CEPHALOTHIN (0.5-32 UG/ML)
- K Number
- K031601
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.1645
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- DADE BEHRING, INC.
- Date Received
- May 21, 2003
- Decision Date
- April 2, 2004
- Product Code
- LON
- 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 |
|---|---|---|---|
| LON | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation | FDA class 2 | Microbiology |
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