510(k) K913906
- Device
- Q FEVER IGG IFA TEST
- Applicant
- HILLCREST BIOLOGICALS
- 510(k) number
- K913906
- Product code
- GPJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1992-10-21
- Date received
- 1991-08-30
- Regulation
- 866.3500
- Classification name
- Antiserum, Fluorescent, Q Fever
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- CAROLYN WAGNER
- Address
- 10703 Progress Way Cypress CA US 90630 90630
FDA Registration Numbers#
- 2023365
- 2027113
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GPJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K922374 | Q FEVER IGM IFA TEST | Hillcrest Biologicals | 1992-10-21 |
Legacy Summary#
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FDA Review#
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