FDA 510(k)
FDA class 2
Substantially Equivalent
🇸🇪 Sweden
ETEST SUBMISSION FOR AZITHROMYCIN/S. PNEUMONIAE
K Number: K970473
·
Decision May 1, 1997
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
433
Applicant Total
64
Review Days
83
Basic Information
- Device Name
- ETEST SUBMISSION FOR AZITHROMYCIN/S. PNEUMONIAE
- K Number
- K970473
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.1640
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- AB BIODISK
- Date Received
- February 7, 1997
- Decision Date
- May 1, 1997
- 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 |
Similar 510(k) Clearances
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The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Vancomycin in the dilution range of 0.25-128 ug/mL
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The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Moxifloxacin in the dilution range of 0.008-16 ug/mL
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Other Clearances by AB BIODISK
| K Number | Device Name | ||
|---|---|---|---|
| K081325 | ETEST DORIPENEM - ANTIMICROBIAL SUSCEPTIBILITY TEST - MIC AT 0.002-32 UG/ML | Jul 24, 2008 | Substantially Equivalent |
| K052366 | ETEST TIGECYCLINE GRAM POSITIVE AND GRAM NEGATIVE AEROBIC BACTERIA, STREPTOCOCCUS SPP. AND ANAEROBIC BACTERIA | Oct 13, 2005 | Substantially Equivalent |
| K042392 | DAPTOMYCIN | Dec 13, 2004 | Substantially Equivalent |
| K042390 | ETEST FOR GEMIFLOXACIN | Nov 19, 2004 | Substantially Equivalent |
| K040560 | ETEST FOR ANTIFUNGAL SUSCEPTTIBILITY TESTING | Jul 27, 2004 | Substantially Equivalent |
| K021445 | ETEST CEFDITOREN FOR S. PNEUMONIAE AND H. INFLUENZAE | Jun 6, 2002 | Substantially Equivalent |
| K020748 | ETEST ERTAPENEM | Apr 29, 2002 | Substantially Equivalent |
| K010363 | ETEST MEROPENEM | Apr 9, 2001 | Substantially Equivalent |
| K002139 | ETEST LINEZOLID | Nov 8, 2000 | Substantially Equivalent |
| K001547 | ETEST ESBL CT/CTL STRIP; ETEST ESBL TZ/TZL STRIP | Aug 7, 2000 | Substantially Equivalent |