GMD
10 FDA 510(k) clearances · Product code
36 daysmedian time to decision
387 days90th percentile
10clearances measured
FDA profile
- Official device name
- Antisera, Latex Agglutination, Cryptococcus Neoformans
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3165
- Medical specialty
- Microbiology
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| CRAG LATERAL FLOW ASSAY (LFA) (K112422) | Immuno-Mycologics, Inc. | 2012-03-28 |
| 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 |
Track GMD automatically
Every clearance here is in the API, with alerts when new ones post.