FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
CAPTIA(R) CMV-G
K Number: K896194
·
Decision Mar 6, 1990
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
57
Applicant Total
17
Review Days
132
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Basic Information
- Device Name
- CAPTIA(R) CMV-G
- K Number
- K896194
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3175
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Mercia Diagnostics , Ltd.
- Date Received
- October 25, 1989
- Decision Date
- March 6, 1990
- Product Code
- LFZ
- 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 |
|---|---|---|---|
| LFZ | Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus | FDA class 2 | Microbiology |
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Other Clearances by Mercia Diagnostics , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K915479 | CAPTIA CMV-TA | May 4, 1992 | Substantially Equivalent |
| K904524 | CAPTIA(R) SYPHILIS M, MODIFICATION | Dec 26, 1990 | Substantially Equivalent |
| K900654 | MODIFIED CAPTIA(R) SYPHILIS-M | Mar 8, 1990 | Substantially Equivalent |
| K896295 | CAPTIA(R) CMV-M | Mar 6, 1990 | Substantially Equivalent |
| K900655 | MODIFIED CAPTIA(R) TOXO-M | Mar 6, 1990 | Substantially Equivalent |
| K883924 | CAPTIA(R) RUBELLA-G | Aug 15, 1989 | Substantially Equivalent |
| K885300 | CAPTIA(R) RUBELLA-M | Aug 15, 1989 | Substantially Equivalent |
| K892802 | SUPER DUO | Jun 13, 1989 | Substantially Equivalent |
| K881425 | CAPTIA(R) SYPHILIS-G | Aug 4, 1988 | Substantially Equivalent |
| K880918 | CAPTIA TOXO-G | Aug 1, 1988 | Substantially Equivalent |