510(k) K864110
- Device
- RICKETTSIAL IGG AND IGM IFA KIT
- Applicant
- HILLCREST BIOLOGICALS
- 510(k) number
- K864110
- Product code
- GPN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-03-12
- Date received
- 1986-10-21
- Regulation
- 866.3500
- Classification name
- Antiserum, Typhus Fever
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- STEVEN A EVANS
- Address
- 10703 Progress Way Cypress CA US 90630 90630
FDA Registration Numbers#
- 2023365
- 1050190
- 3014150341
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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