FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
THE FIAX 5000 FLUOROMETER
K Number: K863434
·
Decision Oct 29, 1986
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
13
Applicant Total
30
Review Days
55
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Basic Information
- Device Name
- THE FIAX 5000 FLUOROMETER
- K Number
- K863434
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.4520
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Whittaker Bioproducts, Inc.
- Date Received
- September 4, 1986
- Decision Date
- October 29, 1986
- Product Code
- JZT
- 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 |
|---|---|---|---|
| JZT | Fluorometer | FDA class 1 | Immunology |
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| K Number | Device Name | ||
|---|---|---|---|
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| K904652 | LYME STAT M TEST KIT | Oct 21, 1991 | Substantially Equivalent |
| K904893 | FIAX LYME M TEST KIT | Oct 16, 1991 | Substantially Equivalent |
| 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 |