CRYPTOCOCCAL ANTIGEN LATEX AGGLUTINATION
FDA 510(k) clearance K791382 · decided 1979-08-16
Clearance details
- K-number
- K791382
- Device name
- CRYPTOCOCCAL ANTIGEN LATEX AGGLUTINATION
- Applicant
- Immuno-Mycologics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1979-07-11
- Decision date
- 1979-08-16
- Days to decision
- 36 days
- Clearance type
- Traditional
- Product code
- GMD
- Device class
- 2
- Regulation number
- 866.3165
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Immuno-Mycologics
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 (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 AGG. SYSTEM (K780526) | I M, Inc. | 1978-04-28 |
Recalls involving this device
No recalls on record reference this clearance.