510(k) K760835
- Device
- Anti-aspergillus Cont. Ser. (mycelial)
- Applicant
- I M, INC.
- 510(k) number
- K760835
- Product code
- KFG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1976-11-01
- Date received
- 1976-10-13
- 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#
- 1217183
- 3035708936
- 3037000637
- 1627497
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 |
| K791386 | ANTI-ASPERGILLUS (MYCELIAL) CONTR SERUM | Immuno-Mycologics, Inc. | 1979-08-16 |