510(k) K112422
- Device
- CRAG LATERAL FLOW ASSAY (LFA)
- Applicant
- IMMUNO-MYCOLOGICS, INC.
- 510(k) number
- K112422
- Product code
- GMD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2012-03-28
- Date received
- 2011-08-23
- Regulation
- 866.3165
- Classification name
- Antisera, Latex Agglutination, Cryptococcus Neoformans
- 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
- 2700 Technology Pl. Norman OK US 73071 73071
FDA Registration Numbers#
- 3003750284
- 1627497
- 1924669
- 3014655875
- 8010096
- 2029372
- 1524213
Source Documents#
Other 510(k) Records For Product Code GMD #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K102286 | CRAG LATERAL FLOW ASSAY (CRAG LFA) | Immuno-Mycologics, Inc. | 2011-07-20 |
| K930418 | CRYPTO-LEX SYSTEM | Trinity Laboratories, Inc. | 1994-02-17 |
| K933997 | PROSPECT ENTAMOEBA HISTOLYTICA MICROPLATE ASSAY | Alexon Biomedical, Inc. | 1993-11-22 |
| K894845 | (CALAS(TM)) W/ADD'L REAGENT CALAS(TM) PRONASE | Meridian Diagnostics, Inc. | 1989-09-08 |
| K812188 | CRYPTOCOCCAL ANTIGEN LATEX AGGLUTI | American Scientific Products | 1981-08-31 |
| K810510 | YA-CRYPTO ANTIBODY TUBE AGGLUTINATION | Immuno-Mycologics, Inc. | 1981-03-20 |
| K792693 | CRYPTOCOCCUS NEOFORMANS ANTISERUM, LATEX | Meridian Diagnostics, Inc. | 1980-01-21 |
| K791382 | CRYPTOCOCCAL ANTIGEN LATEX AGGLUTINATION | Immuno-Mycologics, Inc. | 1979-08-16 |
| K780526 | CRYPTOCOCCAL ANTIGEN LATEX AGG. SYSTEM | I M, Inc. | 1978-04-28 |
Legacy Summary#
summary
FDA Review#
Decision Summary