FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LUTEINIZING HORMONE DIRECT RIA KIT 125/I
K Number: K811024
·
Decision May 8, 1981
Classifications
1
FEI Numbers
82
Registration Numbers
82
Same Product Code
142
Applicant Total
43
Review Days
23
Basic Information
- Device Name
- LUTEINIZING HORMONE DIRECT RIA KIT 125/I
- K Number
- K811024
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1485
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Immunalysis Corporation
- Date Received
- April 15, 1981
- Decision Date
- May 8, 1981
- Product Code
- CEP
- 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 |
|---|---|---|---|
| CEP | Radioimmunoassay, Luteinizing Hormone | FDA class 1 | Clinical Chemistry |
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