FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HARDYDISK AZTREONAM, 30MCG
K Number: K994063
·
Decision Jan 14, 2000
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
322
Applicant Total
88
Review Days
44
Basic Information
- Device Name
- HARDYDISK AZTREONAM, 30MCG
- K Number
- K994063
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.1620
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- HARDY DIAGNOSTICS
- Date Received
- December 1, 1999
- Decision Date
- January 14, 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 HARDY DIAGNOSTICS
| K Number | Device Name | ||
|---|---|---|---|
| K160512 | HardyCHROM ESBL | Nov 15, 2016 | Substantially Equivalent |
| K152846 | HardyDisk AST Ceftolozane/Tazobactam, (30/10ug)- C/T40 | Nov 24, 2015 | Substantially Equivalent |
| K152838 | HardyDisk AST Ceftazidime/Avibactam, (30/20ug)-CZA50 | Nov 24, 2015 | Substantially Equivalent |
| K102922 | HARDYCHROM MRSA | May 4, 2011 | Substantially Equivalent |
| K103538 | HARDYDISK AST CEFTAROLINE, 30 UG MODEL Z939 | Dec 17, 2010 | Substantially Equivalent |
| K093807 | HARDYDISK AST TELAVANCIN,30UG | Jan 8, 2010 | Substantially Equivalent |
| K080019 | HARDYDISK AST DORIPENEM 10 UG | Jan 29, 2008 | Substantially Equivalent |
| K062245 | HARDY DISK AST TIGECYCLINE 15 UG, MODELZ936 | Aug 23, 2006 | Substantially Equivalent |
| K011384 | HARDYDISK NOVOBIOCIN, 30MCG, MODEL Z883 | Jun 13, 2001 | Substantially Equivalent |
| K011385 | HARDKYDISK NEOMYCIN, 30 MCG | May 18, 2001 | Substantially Equivalent |