510(k) K850003
- Device
- COXSACKIE B SERIES CF ANTIGENS
- Applicant
- HILLCREST BIOLOGICALS
- 510(k) number
- K850003
- Product code
- GNG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-03-05
- Date received
- 1985-01-02
- Regulation
- 866.3145
- Classification name
- Antigens, Cf (including Cf Control), 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
Other 510(k) Records For Product Code GNG #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K921618 | COXSACKIE VIRUS B1-B6 CF ANTIGENS | Virion (U.S.), Inc. | 1992-06-29 |
Legacy Summary#
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FDA Review#
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