Candida Albicans, Antiserum
FDA 510(k) K792713 · Meridian Diagnostics, Inc.
510(k) numberK792713
Submission
- Device name
- Candida Albicans, Antiserum
- Applicant
- Meridian Diagnostics, Inc.
Mchenry, IL, US - Received
- December 27, 1979
- Decision date
- January 23, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GMI – Antigen, Cf And / Or Id, Coccidioides Immitis
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3135
- Specialty
- Microbiology
Other 510(k)s with product code GMI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K894617 | Olympus Pk-Tp System Reactive ControlGMI · Traditional | Schiff & Co. | 10/31/1989SE |
| K812190 | Coccidioides Immunodiffusion SystemGMI · Traditional | American Scientific Products | 08/31/1981SE |
| K812185 | Fungal Immunodiffusion SystemGMI · Traditional | American Scientific Products | 08/25/1981SE |
| K802129 | Immunodiffusion Reagents/SerologicalGMI · Traditional | Nolan Biological Laboratories, Inc. | 09/26/1980SE |
| K792716 | Candida Albicans, AntigenGMI · Traditional | Meridian Diagnostics, Inc. | 01/24/1980SE |
| K792689 | Coccidioides Immitis, AntigenGMI · Traditional | Meridian Diagnostics, Inc. | 01/17/1980SE |
| K792682 | Coccidioides Immitis, AntigenGMI · Traditional | Meridian Diagnostics, Inc. | 01/17/1980SE |
| K791389 | Coccidioides Antigen #CF10023XGMI · Traditional | Immuno-Mycologics, Inc. | 08/16/1979SE |
| K791383 | Candida Immunodiffusion Kit #CA1001GMI · Traditional | Immuno-Mycologics, Inc. | 08/16/1979SE |
| K770527 | Candida Immunodiffusion KitGMI · Traditional | I M, Inc. | 03/17/1978SE |
More from I M, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K993914 | Premier Toxins A&B, Model 616096LLH · Special | 12/10/1999SE |
| K990263 | Immunocard Stat! E. Coli O157:H7GMZ · Traditional | 08/09/1999SE |
| K984346 | Premier Type Specific HSV-2 Igg Elisa TestLGC · Traditional | 06/25/1999SE |
| K984343 | Premier Type Specific HSV-1 Igg Elisa TestMXJ · Traditional | 06/25/1999SE |
| K983255 | Modification to: Premier Platinum HpsaLYR · Traditional | 12/17/1998SE |
| K982764 | Premier CryptosporidiumMHJ · Traditional | 12/03/1998SE |
| K982711 | Premier GiardiaMHI · Traditional | 11/25/1998SE |
| K980076 | Premier Platinum HpsaLYR · Traditional | 05/12/1998SE |
| K980077 | Para-Pak SpinconLKS · Traditional | 04/02/1998SE |
| K971585 | Immunocard Stat! RotavirusLIQ · Traditional | 08/20/1997SE |
Questions and answers
When was Candida Albicans, Antiserum cleared by the FDA?
Candida Albicans, Antiserum (K792713) received a 510(k) decision of Substantially Equivalent on January 23, 1980, 27 days after the submission was received.
What is the product code of K792713?
The FDA product code is GMI – Antigen, Cf And / Or Id, Coccidioides Immitis, a Class II (moderate risk) device regulated under 21 CFR 866.3135.