Fungal Immunodiffusion System
FDA 510(k) K812185 · American Scientific Products
510(k) numberK812185
Submission
- Device name
- Fungal Immunodiffusion System
- Applicant
- American Scientific Products
Mchenry, IL, US - Received
- August 3, 1981
- Decision date
- August 25, 1981
- 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 |
| 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 |
| 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 |
|---|---|---|
| K864824 | Infectious Tissue Kit · Traditional | 12/24/1986SE |
| K844042 | Blood Dilution VialGKL · Traditional | 10/23/1984SE |
| K831634 | Glucose Reagent B6360-11CGA · Traditional | 07/19/1983SE |
| K831626 | Urea Nitrogen-Bun-Reagents B6370-11ACDQ · Traditional | 07/07/1983SE |
| K831625 | Urea Nitrogen-Bun-Reagents B6360-12CDQ · Traditional | 07/07/1983SE |
| K831628 | Creatinine Reagents B6370-13CGX · Traditional | 07/06/1983SE |
| K831627 | Creatinine Reagents B6360-10CGX · Traditional | 07/06/1983SE |
| K831624 | Glucose Reagent KITS-B6370-10ACGA · Traditional | 07/06/1983SE |
| K831571 | RotorJJG · Traditional | 06/30/1983SE |
| K831569 | Reagent CupsJJG · Traditional | 06/30/1983SE |
Questions and answers
When was Fungal Immunodiffusion System cleared by the FDA?
Fungal Immunodiffusion System (K812185) received a 510(k) decision of Substantially Equivalent on August 25, 1981, 22 days after the submission was received.
What is the product code of K812185?
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.