FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ANTINUCLEAR ANTOBODY CELL SUBSTRATE
K Number: K822607
·
Decision Sep 17, 1982
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
109
Applicant Total
15
Review Days
21
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Basic Information
- Device Name
- ANTINUCLEAR ANTOBODY CELL SUBSTRATE
- K Number
- K822607
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5100
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Immulok, Inc.
- Date Received
- August 27, 1982
- Decision Date
- September 17, 1982
- 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 Immulok, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K830971 | HERPES SIMPLEX VIRUS TYPING REAGENTS | Jun 30, 1983 | Substantially Equivalent |
| K830342 | CULUTURE SET CHLAMYDIA ISOLATION AND | May 4, 1983 | Substantially Equivalent |
| K830250 | CVT VIRAL TRANSPORTS | Feb 28, 1983 | Substantially Equivalent |
| K823304 | RIASET PROLACTIN RIA KIT | Dec 22, 1982 | Substantially Equivalent |
| K822785 | FLUOROSET IMMUNOFLUORESCENT ANTIBODY | Nov 29, 1982 | Substantially Equivalent |
| K823055 | FLOUROSET IMMUNOFLUORESCENT ANTIBODY | Nov 5, 1982 | Substantially Equivalent |
| K822606 | CYTOMEGALOVIRUS ANTOBODY IGG | Nov 1, 1982 | Substantially Equivalent |
| K822605 | TOXOPLASMA GONDII ANTIBODY IGG | Oct 27, 1982 | Substantially Equivalent |
| K821567 | IMMULOK CULTURESET | Jun 25, 1982 | Substantially Equivalent |
| K821411 | HISTOSET IMMUNOPEROFIDASE TISSUE | Jun 25, 1982 | Substantially Equivalent |