510(k) K831607
- Device
- FIAX IGA TEST KIT
- Applicant
- INTL. DIAGNOSTIC TECHNOLOGY
- 510(k) number
- K831607
- Product code
- CZN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-06-22
- Date received
- 1983-05-18
- Regulation
- 866.5510
- Classification name
- Iga, Fitc, Antigen, Antiserum, Control
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 9610099
- 3013059683
- 3003423869
- 3009189893
- 1618982
- 3019906
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code CZN #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K891683 | TITAN GEL IFE FREE KAPPA/LAMBA LIGHT CHAIN ANTISER | Helena Laboratories | 1989-04-12 |
| K855011 | QUANTIMETRIC PLUS C3 REAGENT KIT | Kallestad Laboratories, Inc. | 1986-02-26 |
| K841815 | OPTIMATE IGA TEST | Miles Laboratories, Inc. | 1984-06-01 |
| K832262 | FITC GOAT ANTI-HUMAN IMMUNOGLOBULINS | Gelco Diagnostics, Inc. | 1983-10-31 |
| K832257 | GOAT ANTI-HUMAN IGA A CHAIN SPECIFIC | Gelco Diagnostics, Inc. | 1983-10-28 |
| K831909 | RABBIT ANTISERUM TO HUMAN IGA | Dako Corp. | 1983-07-18 |
Legacy Summary#
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FDA Review#
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