510(k) K772345
- Device
- FLUORESCEIN CONJUG. FRACT. MONO. ANTI.
- Applicant
- KALLESTAD LABORATORIES, INC.
- 510(k) number
- K772345
- Product code
- DCB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1978-01-05
- Date received
- 1977-12-23
- Regulation
- 866.5520
- Classification name
- Fab, Fitc, Antigen, Antiserum, Control
- Medical specialty
- Immunology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
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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