Immunodiffusion Reagents/Serological
FDA 510(k) K802129 · Nolan Biological Laboratories, Inc.
510(k) numberK802129
Submission
- Device name
- Immunodiffusion Reagents/Serological
- Applicant
- Nolan Biological Laboratories, Inc.
Mchenry, IL, US - Received
- August 4, 1980
- Decision date
- September 26, 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 |
| 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 |
|---|---|---|
| K812741 | Reagents for Serodiagnosis of CandidosisLHK · Traditional | 10/23/1981SE |
| K812740 | Reagents for Serodiagnosis of AspergillJWT · Traditional | 10/20/1981SE |
| K802130 | Immuno. Identification of H. CapsulatumGMJ · Traditional | 09/26/1980SE |
| K802128 | Immunodiffussion Reagents/SerologicalJWW · Traditional | 09/26/1980SE |
Questions and answers
When was Immunodiffusion Reagents/Serological cleared by the FDA?
Immunodiffusion Reagents/Serological (K802129) received a 510(k) decision of Substantially Equivalent on September 26, 1980, 53 days after the submission was received.
What is the product code of K802129?
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.