FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MULTIPURPOSE IMMUNOCHEMISTRY SYSTEM LA-2000 LATEX
K Number: K864342
·
Decision Dec 1, 1986
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
60
Applicant Total
2
Review Days
27
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Basic Information
- Device Name
- MULTIPURPOSE IMMUNOCHEMISTRY SYSTEM LA-2000 LATEX
- K Number
- K864342
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5510
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Eiken Chemical Co., Inc.
- Date Received
- November 4, 1986
- Decision Date
- December 1, 1986
- Product Code
- CFN
- Advisory Committee
- Immunology
- 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 |
|---|---|---|---|
| CFN | Method, Nephelometric, Immunoglobulins (G, A, M) | FDA class 2 | Immunology |
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Other Clearances by Eiken Chemical Co., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K853391 | MULTIPURPOSE IMMUNOCHEMISTRY SYS-LA-2000 | Oct 1, 1985 | Substantially Equivalent |