FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
EA-D IGM ELISA TEST SYSTEM
K Number: K982350
·
Decision Nov 25, 1998
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
55
Applicant Total
13
Review Days
142
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Basic Information
- Device Name
- EA-D IGM ELISA TEST SYSTEM
- K Number
- K982350
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3235
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Columbia Bioscience, Inc.
- Date Received
- July 6, 1998
- Decision Date
- November 25, 1998
- Product Code
- LSE
- 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 |
|---|---|---|---|
| LSE | Epstein-Barr Virus, Other | 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 |
| 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 |
| 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 |