FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IMMUNO/SLE
K Number: K872910
·
Decision Aug 12, 1987
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
15
Applicant Total
11
Review Days
19
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Basic Information
- Device Name
- IMMUNO/SLE
- K Number
- K872910
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5820
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Immunostics Co., Inc.
- Date Received
- July 24, 1987
- Decision Date
- August 12, 1987
- Product Code
- DHC
- 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 |
|---|---|---|---|
| DHC | System, Test, Systemic Lupus Erythematosus | FDA class 2 | Immunology |
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Other Clearances by Immunostics Co., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K926569 | IMMUNO RA UNDILUTED | Apr 6, 1993 | Substantially Equivalent |
| K902360 | HEMA-SCREEN | Jul 27, 1990 | Substantially Equivalent |
| K894780 | IMMUNO/ASO | Oct 16, 1989 | Substantially Equivalent |
| K883685 | IMMUNO/FEBRILE ANTIGENS | Sep 28, 1988 | Substantially Equivalent |
| K863741 | IMMUNO-CEPT D (BETA-MONOCLONAL) | Nov 13, 1986 | Substantially Equivalent |
| K854619 | DETECTACULT | Mar 3, 1986 | Substantially Equivalent |
| K853105 | IMMUNO-IM | Sep 3, 1985 | Substantially Equivalent |
| K842110 | SLIDE PREGNANCY TEST | Jul 12, 1984 | Substantially Equivalent |
| K834390 | IMMUNO-CRP | Feb 3, 1984 | Substantially Equivalent |
| K834391 | IMMUNO-RA | Feb 3, 1984 | Substantially Equivalent |