510(k) K120946
- Device
- ALPHA CRYPTOCOCCAL ANTIGEN EIA
- Applicant
- IMMUNO-MYCOLOGICS, INC.
- 510(k) number
- K120946
- Product code
- MDU
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2012-12-17
- Date received
- 2012-03-29
- Regulation
- 866.3165
- Classification name
- Antigen, Elisa, Cryptococcus
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- SEAN K BAUMAN
- Address
- 116 S Crawford Ave. Norman OK US 73069 73069
FDA Registration Numbers#
- 1524213
- 3012452932
- 2029372
- 1627497
Source Documents#
Other 510(k) Records For Product Code MDU #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K904393 | PREMIER-CRYPTOCOCCAL ANTIGEN | Meridian Diagnostics, Inc. | 1991-01-25 |
Legacy Summary#
summary
FDA Review#
Decision Summary