Aspergillus SP, Complement Fixation
FDA 510(k) K792700 · Meridian Diagnostics, Inc.
510(k) numberK792700
Submission
- Device name
- Aspergillus SP, Complement Fixation
- Applicant
- Meridian Diagnostics, Inc.
Mchenry, IL, US - Received
- December 27, 1979
- Decision date
- January 17, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JWT – Antigen, Cf, Aspergillus Spp.
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3040
- Specialty
- Microbiology
Other 510(k)s with product code JWT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K812740 | Reagents for Serodiagnosis of AspergillJWT · Traditional | Nolan Biological Laboratories, Inc. | 10/20/1981SE |
| K791387 | Aspergillus Mycelial Antigen #CF10024XJWT · Traditional | Immuno-Mycologics, Inc. | 08/16/1979SE |
| K790672 | Aspergillus Fumigatus, Aspergillus FlavuJWT · Traditional | Diagnostica, Inc. | 05/31/1979SE |
| K760830 | Aspergillus Mycelial AntigenJWT · Traditional | I M, Inc. | 11/01/1976SE |
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| 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 Aspergillus SP, Complement Fixation cleared by the FDA?
Aspergillus SP, Complement Fixation (K792700) received a 510(k) decision of Substantially Equivalent on January 17, 1980, 21 days after the submission was received.
What is the product code of K792700?
The FDA product code is JWT – Antigen, Cf, Aspergillus Spp., a Class I (low risk) device regulated under 21 CFR 866.3040.