510(k) K844695
- Device
- ECHO TYPE 4 CF ANTIGEN
- Applicant
- HILLCREST BIOLOGICALS
- 510(k) number
- K844695
- Product code
- GNL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-03-05
- Date received
- 1984-12-03
- Regulation
- 866.3205
- Classification name
- Antigens, Cf (including Cf Control), Echovirus 1-34
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- LOUIS C CULLMAN
- Address
- 3780 Woodruff Ave. Long Beach CA US 90808 90808
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GNL #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K844967 | ECHO TYPE 9 CF ANTIGEN | Hillcrest Biologicals | 1985-03-05 |
Legacy Summary#
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FDA Review#
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