FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IS BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM
K Number: K983605
·
Decision Dec 16, 1998
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
110
Applicant Total
13
Review Days
63
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Basic Information
- Device Name
- IS BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM
- K Number
- K983605
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3830
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Columbia Bioscience, Inc.
- Date Received
- October 14, 1998
- Decision Date
- December 16, 1998
- Product Code
- LSR
- 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 |
|---|---|---|---|
| LSR | Reagent, Borrelia Serological Reagent | FDA class 2 | 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 |
| 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 |
| 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 |