FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IMMUNO-IM
K Number: K853105
·
Decision Sep 3, 1985
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
58
Applicant Total
11
Review Days
42
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Basic Information
- Device Name
- IMMUNO-IM
- K Number
- K853105
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5640
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Immunostics Co., Inc.
- Date Received
- July 23, 1985
- Decision Date
- September 3, 1985
- Product Code
- KTN
- 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 |
|---|---|---|---|
| KTN | System, Test, Infectious Mononucleosis | FDA class 2 | Immunology |
Similar 510(k) Clearances
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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 |
| K872910 | IMMUNO/SLE | Aug 12, 1987 | Substantially Equivalent |
| K863741 | IMMUNO-CEPT D (BETA-MONOCLONAL) | Nov 13, 1986 | Substantially Equivalent |
| K854619 | DETECTACULT | Mar 3, 1986 | 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 |