510(k) K855011
- Device
- QUANTIMETRIC PLUS C3 REAGENT KIT
- Applicant
- KALLESTAD LABORATORIES, INC.
- 510(k) number
- K855011
- Product code
- CZN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-02-26
- Date received
- 1985-12-16
- 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#
- Contact
- QUINLAN SMITH
- Address
- 1000 Lake Hazeltine Dr. Chaska MN US 55318 55318
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 |
| 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 |
| K831607 | FIAX IGA TEST KIT | Intl. Diagnostic Technology | 1983-06-22 |
Legacy Summary#
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FDA Review#
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