FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FIAX 420 DILUTOR
K Number: K843621
·
Decision Sep 28, 1984
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
139
Applicant Total
29
Review Days
14
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Basic Information
- Device Name
- FIAX 420 DILUTOR
- K Number
- K843621
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2750
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Intl. Diagnostic Technology
- Date Received
- September 14, 1984
- Decision Date
- September 28, 1984
- Product Code
- JQW
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| JQW | Station, Pipetting And Diluting, For Clinical Use | FDA class 1 | Clinical Chemistry |
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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 |
| 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 |
| K832821 | FIAX IGG TEST | Oct 14, 1983 | Substantially Equivalent |