FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IDT ANA STIQ ASSAY
K Number: K832383
·
Decision Aug 31, 1983
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
109
Applicant Total
29
Review Days
43
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- IDT ANA STIQ ASSAY
- K Number
- K832383
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5100
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Intl. Diagnostic Technology
- Date Received
- July 19, 1983
- Decision Date
- August 31, 1983
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DHN), ordered by most recent decision date.
Zeus IFA ANA HEp-2 Test System, Zeus dIFine
FDA 510(k)
FDA Class 2
·Immunology
ImmuGlo HEp-2 Elite IFA
FDA 510(k)
FDA Class 2
·Immunology
AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEM
FDA 510(k)
FDA Class 2
·Immunology
Image Navigator by Immuno Concepts
FDA 510(k)
FDA Class 2
·Immunology
EUROIMMUN IFA 40: HEP-20-10; EUROPATTERN MICROSCOPE AND SOFTWARE
FDA 510(k)
FDA Class 2
·Immunology
NOVA Lite DAPI ANA Kit
FDA 510(k)
FDA Class 2
·Immunology
Other Clearances by Intl. Diagnostic Technology
| K Number | Device Name | ||
|---|---|---|---|
| K850591 | FIAX TOXO-M ANTIBODIES TEST KIT | Apr 30, 1985 | Substantially Equivalent |
| K843570 | FIAX HAPTOGLOBIN TEST KIT | Oct 5, 1984 | Substantially Equivalent |
| K843621 | FIAX 420 DILUTOR | Sep 28, 1984 | Substantially Equivalent |
| K843356 | FIAX 100 FLUOROMETER | Sep 17, 1984 | Substantially Equivalent |
| K842749 | FIAX TOTAL IGE TEST KIT | Aug 28, 1984 | Substantially Equivalent |
| K842071 | FIAX TRANSFERRIN TEST KIT | Jul 11, 1984 | Substantially Equivalent |
| K841174 | RUBELLA ANTIBODY FLUOROIMMUNOASSAY | Jun 7, 1984 | Substantially Equivalent |
| K840867 | ALPHA-1-ANTITRYPSIN, FITC, ANTIGEN | May 11, 1984 | Substantially Equivalent |
| K834140 | ANTINUCLEAR ANTIBODY IMMUNOLOGICAL SYS | Jan 20, 1984 | Substantially Equivalent |
| K833984 | ANTINUCLEAR ANTIBODY IMMUNOLOGICAL | Jan 4, 1984 | Substantially Equivalent |