FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RUBELLA VIRUS IMMUNOLOGICAL TEST SYSTEM
K Number: K911444
·
Decision Aug 30, 1991
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
93
Applicant Total
12
Review Days
151
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Basic Information
- Device Name
- RUBELLA VIRUS IMMUNOLOGICAL TEST SYSTEM
- K Number
- K911444
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3510
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Wampole Laboratories
- Date Received
- April 1, 1991
- Decision Date
- August 30, 1991
- Product Code
- LFX
- 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 |
|---|---|---|---|
| LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | FDA class 2 | Microbiology |
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|---|---|---|---|
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| K875161 | MAT (TM) MICROALBUMIN TEST | Feb 17, 1988 | Substantially Equivalent |
| K791309 | UCG-LYPHOTEST | Jul 30, 1979 | Substantially Equivalent |
| K790986 | RF CONTROLS | Jun 28, 1979 | Substantially Equivalent |
| K781794 | BETA-TEC | Dec 29, 1978 | Substantially Equivalent |
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