FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ANA ANTISERA CONTROL KIT
K Number: K894659
·
Decision Sep 21, 1989
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
109
Applicant Total
15
Review Days
59
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Basic Information
- Device Name
- ANA ANTISERA CONTROL KIT
- K Number
- K894659
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5100
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Lipogen, Inc.
- Date Received
- July 24, 1989
- Decision Date
- September 21, 1989
- Product Code
- DHN
- 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 |
|---|---|---|---|
| DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | FDA class 2 | Immunology |
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Other Clearances by Lipogen, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K902636 | LIPOGEN RHEUMELISA DSDNA ASSAY | Jun 28, 1990 | Substantially Equivalent |
| K895997 | RHEUMELISA ASSAY FOR RNP AUTOANTIBODIES | Nov 6, 1989 | Substantially Equivalent |
| K895996 | RHEUMELISA ASSAY FOR SM AUTOANTIBODIES | Nov 6, 1989 | Substantially Equivalent |
| K895995 | RHEUMELISA ASSAY FOR SS-B/LA AUTOANTIBODIES | Oct 27, 1989 | Substantially Equivalent |
| K895994 | RHEUMELISA ASSAY FOR SS-A/RO AUTOANTIBODIES | Oct 24, 1989 | Substantially Equivalent |
| K892421 | MODIFIED ACCESS R-CLONE ANA/RF SCREENING TEST | May 9, 1989 | Substantially Equivalent |
| K885048 | ACCESS R-CLONE ANA PROFILE ASSAY | Jan 24, 1989 | Substantially Equivalent |
| K882740 | ACCESS R-CLONE(TM) ANA/RF SCREENING ASSAY | Sep 22, 1988 | Substantially Equivalent |
| K880254 | SM ANTIBODY TEST KIT | Apr 6, 1988 | Substantially Equivalent |
| K874152 | RNP ANTIBODY TEST KIT | Mar 11, 1988 | Substantially Equivalent |