FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SERIM DISINTEK REAGENT STRIPS
K Number: K913943
·
Decision Mar 26, 1992
Classifications
1
FEI Numbers
41
Registration Numbers
41
Same Product Code
62
Applicant Total
27
Review Days
204
Basic Information
- Device Name
- SERIM DISINTEK REAGENT STRIPS
- K Number
- K913943
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6885
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- SERIM RESEARCH CORP.
- Date Received
- September 4, 1991
- Decision Date
- March 26, 1992
- 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 (P6500); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6800); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6900)
FDA 510(k)
FDA Class 2
·General Hospital
SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900
FDA 510(k)
FDA Class 2
·General Hospital
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
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
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
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
FDA 510(k)
FDA Class 2
·General Hospital
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