510(k) K921618
- Device
- COXSACKIE VIRUS B1-B6 CF ANTIGENS
- Applicant
- VIRION (U.S.), INC.
- 510(k) number
- K921618
- Product code
- GNG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1992-06-29
- Date received
- 1992-04-06
- 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
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- WILLIAM J HAUSLER
- Address
- 4 Upperfield Rd. Morristown NJ US 07960 07960
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GNG #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K850003 | COXSACKIE B SERIES CF ANTIGENS | Hillcrest Biologicals | 1985-03-05 |
Legacy Summary#
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FDA Review#
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