FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DIAZYME APOLIPOPROTEIN B ASSAY, MODEL DZXXX-X; B CALIBRATOR, MODEL DZXXX
K Number: K073488
·
Decision Mar 7, 2008
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
49
Applicant Total
41
Review Days
137
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Basic Information
- Device Name
- DIAZYME APOLIPOPROTEIN B ASSAY, MODEL DZXXX-X; B CALIBRATOR, MODEL DZXXX
- K Number
- K073488
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1475
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Diazyme Laboratories
- Date Received
- October 22, 2007
- Decision Date
- March 7, 2008
- Product Code
- MSJ
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MSJ), ordered by most recent decision date.
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FDA 510(k)
FDA Class 1
·Clinical Chemistry
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