510(k) K790672
- Device
- ASPERGILLUS FUMIGATUS, ASPERGILLUS FLAVU
- Applicant
- DIAGNOSTICA, INC.
- 510(k) number
- K790672
- Product code
- JWT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1979-05-31
- Date received
- 1979-04-06
- Regulation
- 866.3040
- Classification name
- Antigen, Cf, Aspergillus Spp.
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 1627497
- 3003718445
- 3012452932
- 3016587486
- 2245285
- 3002800697
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JWT #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K812740 | REAGENTS FOR SERODIAGNOSIS OF ASPERGILL | Nolan Biological Laboratories, Inc. | 1981-10-20 |
| K792700 | ASPERGILLUS SP, COMPLEMENT FIXATION | Meridian Diagnostics, Inc. | 1980-01-17 |
| K791387 | ASPERGILLUS MYCELIAL ANTIGEN #CF10024X | Immuno-Mycologics, Inc. | 1979-08-16 |
| K760830 | ASPERGILLUS MYCELIAL ANTIGEN | I M, Inc. | 1976-11-01 |
Legacy Summary#
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FDA Review#
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