510(k) K792691
- Device
- CRYPTOCOCCUS NEOFORMANS, ANTIGEN,
- Applicant
- MERIDIAN DIAGNOSTICS, INC.
- 510(k) number
- K792691
- Product code
- JWK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1980-01-17
- Date received
- 1979-12-27
- Regulation
- 866.3165
- Classification name
- Antigen, Positive Control, Cryptococcus Neoformans
- 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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