510(k) K791386
- Device
- ANTI-ASPERGILLUS (MYCELIAL) CONTR SERUM
- Applicant
- IMMUNO-MYCOLOGICS, INC.
- 510(k) number
- K791386
- Product code
- KFG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1979-08-16
- Date received
- 1979-07-11
- Regulation
- 866.3040
- Classification name
- Antiserum, Positive Control, 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#
- 3037000637
- 1627497
- 3035708936
- 1217183
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KFG #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K904499 | NICOS (NON-INVASIVE CARDIAC OUTPUT SYSTEM) | Ackrad Laboratories | 1991-07-01 |
| K792686 | ASPERGILLUS SP, ANTISERUM POSITIVE | Meridian Diagnostics, Inc. | 1980-01-17 |
| K792698 | ASPERGILLUS SP, ANTISERUM, POSITIVE | Meridian Diagnostics, Inc. | 1980-01-17 |
| K760835 | ANTI-ASPERGILLUS CONT. SER. (MYCELIAL) | I M, Inc. | 1976-11-01 |
Legacy Summary#
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FDA Review#
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