FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FIAX TEST KIT FOR ENA (RNP/SM) ANTIBODIES
K Number: K873708
·
Decision Nov 25, 1987
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
179
Applicant Total
30
Review Days
71
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Basic Information
- Device Name
- FIAX TEST KIT FOR ENA (RNP/SM) ANTIBODIES
- K Number
- K873708
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5100
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Whittaker Bioproducts, Inc.
- Date Received
- September 15, 1987
- Decision Date
- November 25, 1987
- Product Code
- LLL
- Advisory Committee
- Immunology
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| LLL | Extractable Antinuclear Antibody, Antigen And Control | FDA class 2 | Immunology |
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Other Clearances by Whittaker Bioproducts, Inc.
| K Number | Device Name | ||
|---|---|---|---|
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| K911473 | EBNA STAT TEST KIT | Sep 25, 1991 | Substantially Equivalent |
| K905468 | PYLORI-G FIAX TEST KIT | May 7, 1991 | Substantially Equivalent |
| K904738 | PYLORI STAT TEST KIT | May 7, 1991 | Substantially Equivalent |
| K901493 | FITC MURINE MONOCLONAL ANTI-INFLUENZA TYPE B | Jun 27, 1990 | Substantially Equivalent |
| K893579 | FITC MURINE MONOCLONAL ANTI-INFLUENZA TYPE A | Jan 16, 1990 | Substantially Equivalent |
| K894932 | FIAX EB VCA-M TEST KIT | Oct 16, 1989 | Substantially Equivalent |