510(k) K843672
- Device
- Q-FEVER
- Applicant
- INSTITUTE VIRION LTD.
- 510(k) number
- K843672
- Product code
- GPS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-08-08
- Date received
- 1984-09-17
- Regulation
- 866.3500
- Classification name
- Antigen, Cf, Q Fever
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 4221 Richmond Rd., NW Walker MI US 49534 49534
FDA Registration Numbers#
- 3004036192
- 9615056
- 1050190
- 3008191245
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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