510(k) K843286
- Device
- EI-CANDIDA ENZYME IMMUNOASSAY EI1001
- Applicant
- IMMUNO-MYCOLOGICS, INC.
- 510(k) number
- K843286
- Product code
- LRF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-10-01
- Date received
- 1984-08-21
- Regulation
- 866.3165
- Classification name
- Candida Spp., Direct Antigen, Id
- 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
FDA Registration Numbers#
- 8030124
- 1645225
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LRF #
Legacy Summary#
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FDA Review#
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