FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS WITH ERTAPENEM (0.002-32 MCG/ML
K Number: K032706
·
Decision Feb 10, 2004
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
433
Applicant Total
343
Review Days
161
Basic Information
- Device Name
- MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS WITH ERTAPENEM (0.002-32 MCG/ML
- K Number
- K032706
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.1640
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- DADE BEHRING, INC.
- Date Received
- September 2, 2003
- Decision Date
- February 10, 2004
- Product Code
- JWY
- 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 |
|---|---|---|---|
| JWY | Manual Antimicrobial Susceptibility Test Systems | FDA class 2 | Microbiology |
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