510(k) K854483
- Device
- KALLESTAD QUANTIMETRIC PLUS IGG REAGENT KIT
- Applicant
- KALLESTAD LABORATORIES, INC.
- 510(k) number
- K854483
- Product code
- KTO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-12-11
- Date received
- 1985-11-07
- Regulation
- 866.5530
- Classification name
- Reagent, Immunoassay, Igg
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 1
- 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#
- 8030124
- 3003272500
- 3014325803
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KTO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K894416 | RAICHEM(TM) SPIA(TM) IGG REAGENTS | Reagents Applications, Inc. | 1989-08-01 |
Legacy Summary#
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FDA Review#
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