FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL - TRIMETHOPRIM/SULFAMETHOXAZOLE
K Number: K020686
·
Decision Apr 30, 2002
Classifications
1
FEI Numbers
9
Registration Numbers
9
Same Product Code
440
Applicant Total
40
Review Days
57
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Basic Information
- Device Name
- MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL - TRIMETHOPRIM/SULFAMETHOXAZOLE
- K Number
- K020686
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.1640
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dade Microscan, Inc.
- Date Received
- March 4, 2002
- Decision Date
- April 30, 2002
- 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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Other Clearances by Dade Microscan, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K043589 | MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS - ERTAPENEM | Feb 14, 2005 | Substantially Equivalent |
| K023202 | MICROSCAN SYNERGIES PLUS | Oct 23, 2002 | Substantially Equivalent |
| K021184 | MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-CLINDAMYCIN | Jun 20, 2002 | Substantially Equivalent |
| K021181 | MICROSCAN MICROSTREP PLUS PANEL NEW ANTICROBIAL-CLARITHROMYCIN | Jun 17, 2002 | Substantially Equivalent |
| K021018 | MICROSCAN MICROSTREP PLUS PANEL - CHLORAMPHENICOL | Jun 11, 2002 | Substantially Equivalent |
| K021188 | MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-CEFEPIME | Jun 6, 2002 | Substantially Equivalent |
| K021169 | MICROSTREP PLUS PANEL, AZITHROMYCIN | Jun 6, 2002 | Substantially Equivalent |
| K021111 | MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL - CEFOTAXIME | Jun 6, 2002 | Substantially Equivalent |
| K021078 | MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-ERYTHROMYCIN | Jun 6, 2002 | Substantially Equivalent |
| K021110 | MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL- CEFTRIAXONE | Jun 6, 2002 | Substantially Equivalent |