FDA 510(k)
FDA class 1
Substantially Equivalent
🇮🇱 Israel
APO B., IMMUNOTURBIDIMETRIC ASSAY
K Number: K864228
·
Decision Mar 12, 1987
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
49
Applicant Total
4
Review Days
135
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Basic Information
- Device Name
- APO B., IMMUNOTURBIDIMETRIC ASSAY
- K Number
- K864228
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1475
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Intl. Diagnostic Laboratories, Ltd.
- Date Received
- October 28, 1986
- Decision Date
- March 12, 1987
- Product Code
- MSJ
- Advisory Committee
- Clinical Chemistry
- 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 |
|---|---|---|---|
| MSJ | Apolipoproteins | FDA class 1 | Clinical Chemistry |
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