510(k) K904393
- Device
- PREMIER-CRYPTOCOCCAL ANTIGEN
- Applicant
- MERIDIAN DIAGNOSTICS, INC.
- 510(k) number
- K904393
- Product code
- MDU
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1991-01-25
- Date received
- 1990-09-25
- Regulation
- 866.3165
- Classification name
- Antigen, Elisa, Cryptococcus
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- ALLEN NICKOL
- Address
- 3471 River Hills Dr. Cincinnati OH US 45244 45244
FDA Registration Numbers#
- 1524213
- 3012452932
- 2029372
- 1627497
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code MDU #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K120946 | ALPHA CRYPTOCOCCAL ANTIGEN EIA | Immuno-Mycologics, Inc. | 2012-12-17 |
Legacy Summary#
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FDA Review#
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