FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ISOENZYME TEST LD-1
K Number: K850210
·
Decision Mar 29, 1985
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
27
Applicant Total
82
Review Days
73
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Basic Information
- Device Name
- ISOENZYME TEST LD-1
- K Number
- K850210
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1445
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Sclavo, Inc.
- Date Received
- January 15, 1985
- Decision Date
- March 29, 1985
- Product Code
- CFE
- 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 |
|---|---|---|---|
| CFE | Electrophoretic, Lactate Dehydrogenase Isoenzymes | FDA class 2 | Clinical Chemistry |
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