FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
METRICIDE 28
K Number: K931052
·
Decision Dec 6, 1994
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
63
Applicant Total
6
Review Days
658
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Basic Information
- Device Name
- METRICIDE 28
- K Number
- K931052
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6885
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Metrex Research Corp.
- Date Received
- February 16, 1993
- Decision Date
- December 6, 1994
- Product Code
- MED
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| MED | Sterilant, Medical Devices | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MED), ordered by most recent decision date.
SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900
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SYSTEM 1E Liquid Chemical Sterilant Processing System (P6500); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6800); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6900)
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SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900
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SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant Concentrate
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SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant Concentrate
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SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant Concentrate
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by Metrex Research Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K981023 | KLEENASEPTIC | Apr 30, 1998 | Substantially Equivalent |
| K950516 | COLDCIDE-10 | Mar 22, 1995 | Substantially Equivalent |
| K950553 | COLDCIDE-2 | Mar 22, 1995 | Substantially Equivalent |
| K930284 | METRICIDE | Dec 6, 1994 | Substantially Equivalent |
| K931592 | METRICIDE PLUS 30 LIQUID CHEMICAL GERMICIDE | Dec 6, 1994 | Substantially Equivalent |