FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ANA TEST KIT
K Number: K864668
·
Decision Mar 12, 1987
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
49
Applicant Total
11
Review Days
100
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Basic Information
- Device Name
- ANA TEST KIT
- K Number
- K864668
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5100
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Val Tech Diagnostics, Inc.
- Date Received
- December 2, 1986
- Decision Date
- March 12, 1987
- Product Code
- LKJ
- 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 |
|---|---|---|---|
| LKJ | Antinuclear Antibody, Antigen, Control | FDA class 2 | Immunology |
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Other Clearances by Val Tech Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K883570 | HISTO-CHECK FUNGAL CONTROL SLIDES | Oct 6, 1988 | Substantially Equivalent |
| K883571 | HISTO-CHECK PARASITIC CONTROL SLIDES | Oct 6, 1988 | Substantially Equivalent |
| K883569 | HISTO-CHECK GRAM NEGATIVE SLIDES | Oct 6, 1988 | Substantially Equivalent |
| K883568 | HISTO-CHECK ACID FAST SLIDES | Oct 6, 1988 | Substantially Equivalent |
| K883567 | HISTO-CHECK LEGIONELLA CONTROL SLIDES | Oct 6, 1988 | Substantially Equivalent |
| K883684 | HERPES VIRUS CONTROL SLIDES | Sep 28, 1988 | Substantially Equivalent |
| K883232 | HISTONE REACTIVE ANA | Sep 7, 1988 | Substantially Equivalent |
| K883208 | HISTO-CHECK SLIDES | Aug 25, 1988 | Substantially Equivalent |
| K871395 | DUAL SUBSTRATE ANA | Apr 20, 1987 | Substantially Equivalent |
| K870732 | RAT LIVER NUCLEI TEST SYSTEM | Mar 10, 1987 | Substantially Equivalent |