FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
IS H. PYLORI IGG ELISA TEST SYSTEM
K Number: K990462
·
Decision Sep 3, 1999
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
90
Applicant Total
13
Review Days
203
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Basic Information
- Device Name
- IS H. PYLORI IGG ELISA TEST SYSTEM
- K Number
- K990462
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3110
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Columbia Bioscience, Inc.
- Date Received
- February 12, 1999
- Decision Date
- September 3, 1999
- Product Code
- LYR
- 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 |
|---|---|---|---|
| LYR | Helicobacter Pylori | FDA class 1 | Microbiology |
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Other Clearances by Columbia Bioscience, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K991274 | MUMPS 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 |