FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OLYMPUS FERRITIN IMMUNOTURBIDIMETRIC REAGENT
K Number: K963170
·
Decision Dec 2, 1996
Classifications
1
FEI Numbers
41
Registration Numbers
41
Same Product Code
86
Applicant Total
149
Review Days
110
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Basic Information
- Device Name
- OLYMPUS FERRITIN IMMUNOTURBIDIMETRIC REAGENT
- K Number
- K963170
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5340
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Olympus America, Inc.
- Date Received
- August 14, 1996
- Decision Date
- December 2, 1996
- Product Code
- DBF
- 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 |
|---|---|---|---|
| DBF | Ferritin, Antigen, Antiserum, Control | FDA class 2 | Immunology |
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| K062581 | OLYMPUS TSH REAGENT, CALIBRATOR AND CONTROL AND AU3000I IMMUNOASSAY SYSTEM | Nov 29, 2006 | Substantially Equivalent |
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