510(k) K853279
- Device
- COXSACKIE A2 CF ANTIGEN, A4, A10 & A16
- Applicant
- HILLCREST BIOLOGICALS
- 510(k) number
- K853279
- Product code
- GNO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-11-07
- Date received
- 1985-08-05
- Regulation
- 866.3145
- Classification name
- Antisera, Cf, Coxsackievirus A 1-24, B 1-6
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- LOUIS C CULLMAN
- Address
- 10703 Progress Way Cypress CA US 90630 90630
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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