FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
EZ VIEW
K Number: K925693
·
Decision Jan 15, 1993
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
67
Applicant Total
121
Review Days
64
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Basic Information
- Device Name
- EZ VIEW
- K Number
- K925693
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2560
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Difco Laboratories, Inc.
- Date Received
- November 12, 1992
- Decision Date
- January 15, 1993
- Product Code
- MDB
- 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 |
|---|---|---|---|
| MDB | System, Blood Culturing | FDA class 1 | 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 |