FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DUPONT ACA PLUS LUTEINIZING HORMONE (LH) METHOD
K Number: K943996
·
Decision Oct 20, 1994
Classifications
1
FEI Numbers
73
Registration Numbers
73
Same Product Code
142
Applicant Total
28
Review Days
65
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Basic Information
- Device Name
- DUPONT ACA PLUS LUTEINIZING HORMONE (LH) METHOD
- K Number
- K943996
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1485
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dupont Medical Products
- Date Received
- August 16, 1994
- Decision Date
- October 20, 1994
- Product Code
- CEP
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- TX
- 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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| K941146 | DUPONT ACA PLUS THYROID STIMULATING HORMONE SYSTEM | Oct 3, 1994 | Substantially Equivalent |
| K942640 | DUPONT DIMENSION AMYLASE METHOD | Sep 9, 1994 | Substantially Equivalent |
| K942241 | DUPONT APC BLOOD COLLECTION CONTAINER WITH THROMBOPLASTIN | Aug 18, 1994 | Substantially Equivalent |