Candida Immunodiffusion Kit #CA1001
FDA 510(k) K791383 · Immuno-Mycologics, Inc.
510(k) numberK791383
Submission
- Device name
- Candida Immunodiffusion Kit #CA1001
- Applicant
- Immuno-Mycologics, Inc.
Mchenry, IL, US - Received
- July 11, 1979
- Decision date
- August 16, 1979
- 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 |
| K792713 | Candida Albicans, AntiserumGMI · Traditional | Meridian Diagnostics, Inc. | 01/23/1980SE |
| 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 |
| K770527 | Candida Immunodiffusion KitGMI · Traditional | I M, Inc. | 03/17/1978SE |
More from I M, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K120946 | Alpha Cryptococcal Antigen EiaMDU · Traditional | 12/17/2012SE |
| K112422 | Crag Lateral Flow Assay (Lfa)GMD · Traditional | 03/28/2012SE |
| K102286 | Crag Lateral Flow Assay (Crag Lfa)GMD · Traditional | 07/20/2011SE |
| K101407 | Alpha Histoplasma Antigen Eia Model HAG102MIZ · Traditional | 07/19/2011SE |
| K883333 | Rabbit Plasma Fibrinogen (RPF) SupplementJTL · Traditional | 08/25/1988SE |
| K880029 | Exo-Antigen Identification System Cat.# EX1001KFH · Traditional | 02/24/1988SE |
| K843286 | Ei-Candida Enzyme Immunoassay EI1001LRF · Traditional | 10/01/1984SE |
| K831918 | La-Staph Identification SystemJWX · Traditional | 06/08/1983SE |
| K830837 | La-Histo Antibody System #Hl 1001GMJ · Traditional | 05/05/1983SE |
| K810510 | Ya-Crypto Antibody Tube AgglutinationGMD · Traditional | 03/20/1981SE |
Questions and answers
When was Candida Immunodiffusion Kit #CA1001 cleared by the FDA?
Candida Immunodiffusion Kit #CA1001 (K791383) received a 510(k) decision of Substantially Equivalent on August 16, 1979, 36 days after the submission was received.
What is the product code of K791383?
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.