FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CEFZIL
K Number: K922793
·
Decision Jul 28, 1992
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
322
Applicant Total
121
Review Days
49
Basic Information
- Device Name
- CEFZIL
- K Number
- K922793
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.1620
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- DIFCO LABORATORIES, INC.
- Date Received
- June 9, 1992
- Decision Date
- July 28, 1992
- 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 DIFCO LABORATORIES, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K971211 | DISPENS-O-DISC SPARFLOXACIN | Apr 14, 1997 | Substantially Equivalent |
| K971120 | DISPENS-O-DISC (TM) LEVOFLOXACIN | Apr 14, 1997 | Substantially Equivalent |
| K963508 | DISPENS-O-DISC MEROPENEM | Sep 26, 1996 | Substantially Equivalent |
| K961148 | CEFEPIME DISPANS-O-DISC (CEFEPLIME - 30MCG) | Apr 26, 1996 | Substantially Equivalent |
| K954783 | DRYSLIDE CARTARRHALIS | Feb 6, 1996 | Substantially Equivalent |
| K954784 | DRYSIDE NEISSERIA | Jan 30, 1996 | Substantially Equivalent |
| K953129 | ESP CULTURE SYSTEM - MYCO | Dec 26, 1995 | Substantially Equivalent |
| K950706 | DRYSLIDE COAGULASE | May 16, 1995 | Substantially Equivalent |
| K944275 | DISPENS-O-DISC PIPERACILLIN 100 MCG./TAZOBACTAM 10 MCG. | Dec 19, 1994 | Substantially Equivalent |
| K941016 | DISPENS-O-DISC(TM) NITROCEFIN | Jun 30, 1994 | Substantially Equivalent |