510(k) K101407
- Device
- ALPHA HISTOPLASMA ANTIGEN EIA MODEL HAG102
- Applicant
- IMMUNO-MYCOLOGICS, INC.
- 510(k) number
- K101407
- Product code
- MIZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2011-07-19
- Date received
- 2010-05-19
- Regulation
- 866.3320
- Classification name
- Enzyme Linked Immunoabsorbent Assay, Histoplasma Capsulatum
- 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, PH.D
- Address
- 2700 Technology Pl. Norman OK US 73071 73071
FDA Registration Numbers#
- 3005369540
- 1627497
Source Documents#
Other 510(k) Records For Product Code MIZ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K915700 | PERMIER HISTOPLASMA | Meridian Diagnostics, Inc. | 1992-07-30 |
Legacy Summary#
summary
FDA Review#
Decision Summary