510(k) K894538
- Device
- QM300 ALPHA1-ACID GLYCOPROTEIN ANTIBODY PACK
- Applicant
- KALLESTAD DIAG, A DIV. OF ERBAMONT, INC.
- 510(k) number
- K894538
- Product code
- DBN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-08-04
- Date received
- 1989-07-20
- Regulation
- 866.5530
- Classification name
- Fc, Antigen, Antiserum, Control
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- JAN NEBELSICK
- Address
- 2000 Lake Hazeltine Dr. Chaska MN US 55318 55318
FDA Registration Numbers#
- 3019906
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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