FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MUMPS IGG ELISA TEST SYSTEM
K Number: K991274
·
Decision Sep 3, 1999
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
7
Applicant Total
13
Review Days
143
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Basic Information
- Device Name
- MUMPS IGG ELISA TEST SYSTEM
- K Number
- K991274
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3380
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Columbia Bioscience, Inc.
- Date Received
- April 13, 1999
- Decision Date
- September 3, 1999
- Product Code
- LJY
- 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 |
|---|---|---|---|
| LJY | Enzyme Linked Immunoabsorbent Assay, Mumps Virus | FDA class 1 | Microbiology |
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Other Clearances by Columbia Bioscience, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K990462 | IS H. PYLORI IGG ELISA TEST SYSTEM | Sep 3, 1999 | Substantially Equivalent |
| K984228 | IS ANTI-TPO IGG ELISA TEST SYSTEM | Feb 2, 1999 | Substantially Equivalent |
| K983605 | IS BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM | Dec 16, 1998 | Substantially Equivalent |
| K983606 | IS BORRELIA BURGDORFERI IGM TEST SYSTEM | Dec 16, 1998 | Substantially Equivalent |
| K983553 | ANTI-TG IGG ELISA TEST SYSTEM | Dec 7, 1998 | Substantially Equivalent |
| K982348 | EBNA-1 IGM ELISA TEST SYSTEM | Nov 25, 1998 | Substantially Equivalent |
| K982352 | VCA IGM ELISA TEST SYSTEM | Nov 25, 1998 | Substantially Equivalent |
| K982350 | EA-D IGM ELISA TEST SYSTEM | Nov 25, 1998 | Substantially Equivalent |
| K983740 | IS-ANTI-PR3 IGG ELISA TEST SYSTEM | Nov 18, 1998 | Substantially Equivalent |
| K983390 | IS-ANTI-MPO IGG ELISA TEST SYSTEM | Nov 18, 1998 | Substantially Equivalent |