FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
QUINUPRISTIN/DALFOPRISTIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K Number: K000928
·
Decision May 15, 2000
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
327
Applicant Total
36
Review Days
54
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Basic Information
- Device Name
- QUINUPRISTIN/DALFOPRISTIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
- K Number
- K000928
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.1620
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Oxoid , Ltd.
- Date Received
- March 22, 2000
- Decision Date
- May 15, 2000
- Product Code
- JTN
- 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 |
|---|---|---|---|
| JTN | Susceptibility Test Discs, Antimicrobial | FDA class 2 | Microbiology |
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Other Clearances by Oxoid , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K070262 | ERTAPENEM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | Mar 14, 2007 | Substantially Equivalent |
| K060286 | TIGECYCLINE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | Mar 17, 2006 | Substantially Equivalent |
| K042157 | DAPTOMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | Sep 14, 2004 | Substantially Equivalent |
| K011710 | OXOID PBP2 1 LATEX AGGLUTINATION TEST | Apr 2, 2002 | Substantially Equivalent |
| K012588 | OXOID PYLORI TEST KIT, MODEL DR0130M | Dec 10, 2001 | Substantially Equivalent |
| K010537 | LINEZOLID ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | Apr 24, 2001 | Substantially Equivalent |
| K010536 | MOXIFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | Apr 24, 2001 | Substantially Equivalent |
| K000930 | GATIFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | May 22, 2000 | Substantially Equivalent |
| K993401 | DRYSPOT E.COLI 0157 KIT | Feb 28, 2000 | Substantially Equivalent |
| K984513 | TROVAFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | Apr 2, 1999 | Substantially Equivalent |