510(k) K800328
- Device
- NEISSERIA GONORRHOEAE FLUORO-KIT
- Applicant
- CLINICAL SCIENCES, INC.
- 510(k) number
- K800328
- Product code
- GTH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1980-03-03
- Date received
- 1980-02-12
- Regulation
- 866.3390
- Classification name
- Antiserum, Fluorescent (direct Test), All Groups, N. Gonorrhoeae
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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