CRAG LATERAL FLOW ASSAY (LFA)
FDA 510(k) clearance K112422 · decided 2012-03-28
Clearance details
- K-number
- K112422
- Device name
- CRAG LATERAL FLOW ASSAY (LFA)
- Applicant
- Immuno-Mycologics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-08-23
- Decision date
- 2012-03-28
- Days to decision
- 218 days
- Clearance type
- Traditional
- Product code
- GMD
- Device class
- 2
- Regulation number
- 866.3165
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Norman, OK, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| CRAG LATERAL FLOW ASSAY (CRAG LFA) (K102286) | Immuno-Mycologics, Inc. | 2011-07-20 |
| CRYPTO-LEX SYSTEM (K930418) | Trinity Laboratories, Inc. | 1994-02-17 |
| PROSPECT ENTAMOEBA HISTOLYTICA MICROPLATE ASSAY (K933997) | Alexon Biomedical, Inc. | 1993-11-22 |
| (CALAS(TM)) W/ADD'L REAGENT CALAS(TM) PRONASE (K894845) | Meridian Diagnostics, Inc. | 1989-09-08 |
| CRYPTOCOCCAL ANTIGEN LATEX AGGLUTI (K812188) | American Scientific Products | 1981-08-31 |
| YA-CRYPTO ANTIBODY TUBE AGGLUTINATION (K810510) | Immuno-Mycologics, Inc. | 1981-03-20 |
| CRYPTOCOCCUS NEOFORMANS ANTISERUM, LATEX (K792693) | Meridian Diagnostics, Inc. | 1980-01-21 |
| CRYPTOCOCCAL ANTIGEN LATEX AGGLUTINATION (K791382) | Immuno-Mycologics, Inc. | 1979-08-16 |
| CRYPTOCOCCAL ANTIGEN LATEX AGG. SYSTEM (K780526) | I M, Inc. | 1978-04-28 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Reference # CR2003 recall (Z-1109-2017) | Immuno-Mycologics, Inc | 2017-01-27 |