Reagents for Serodiagnosis of Aspergill
FDA 510(k) K812740 · Nolan Biological Laboratories, Inc.
510(k) numberK812740
Submission
- Device name
- Reagents for Serodiagnosis of Aspergill
- Applicant
- Nolan Biological Laboratories, Inc.
Mchenry, IL, US - Received
- September 29, 1981
- Decision date
- October 20, 1981
- 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 |
|---|---|---|---|
| K792700 | Aspergillus SP, Complement FixationJWT · Traditional | Meridian Diagnostics, Inc. | 01/17/1980SE |
| 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 |
More from I M, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K812741 | Reagents for Serodiagnosis of CandidosisLHK · Traditional | 10/23/1981SE |
| K802130 | Immuno. Identification of H. CapsulatumGMJ · Traditional | 09/26/1980SE |
| K802129 | Immunodiffusion Reagents/SerologicalGMI · Traditional | 09/26/1980SE |
| K802128 | Immunodiffussion Reagents/SerologicalJWW · Traditional | 09/26/1980SE |
Questions and answers
When was Reagents for Serodiagnosis of Aspergill cleared by the FDA?
Reagents for Serodiagnosis of Aspergill (K812740) received a 510(k) decision of Substantially Equivalent on October 20, 1981, 21 days after the submission was received.
What is the product code of K812740?
The FDA product code is JWT – Antigen, Cf, Aspergillus Spp., a Class I (low risk) device regulated under 21 CFR 866.3040.