FDA product code KFG: Antiserum, Positive Control, Aspergillus Spp.
KFG is the FDA product code for antiserum, positive control, aspergillus spp.. It is a Class I device, regulated under 21 CFR 866.3040 and reviewed by the Microbiology panel. FDA has cleared 5 510(k) submissions under KFG, from 4 different applicants. The average 510(k) review took 74 days (median 21).
Classification
| Field | Value |
|---|---|
| Device name | Antiserum, Positive Control, Aspergillus Spp. |
| Device class | Class I |
| Regulation | 21 CFR 866.3040 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every KFG clearance
Top KFG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Meridian Diagnostics, Inc. | 2 | 1980-01-17 |
| Ackrad Laboratories | 1 | 1991-07-01 |
| Immuno-Mycologics, Inc. | 1 | 1979-08-16 |
| I M, Inc. | 1 | 1976-11-01 |
Most recent KFG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K904499 | Ackrad Laboratories | NICOS (NON-INVASIVE CARDIAC OUTPUT SYSTEM) | 1991-07-01 | 273 |
| K792686 | Meridian Diagnostics, Inc. | ASPERGILLUS SP, ANTISERUM POSITIVE | 1980-01-17 | 21 |
| K792698 | Meridian Diagnostics, Inc. | ASPERGILLUS SP, ANTISERUM, POSITIVE | 1980-01-17 | 21 |
| K791386 | Immuno-Mycologics, Inc. | ANTI-ASPERGILLUS (MYCELIAL) CONTR SERUM | 1979-08-16 | 36 |
| K760835 | I M, Inc. | ANTI-ASPERGILLUS CONT. SER. (MYCELIAL) | 1976-11-01 | 19 |
Recalls for KFG devices
openFDA lists no recalls for product code KFG.
Frequently asked questions
What is FDA product code KFG?
KFG is the FDA product code for antiserum, positive control, aspergillus spp.. It is a Class I device, regulated under 21 CFR 866.3040 and reviewed by the Microbiology panel.
What device class is KFG?
Class I, regulation 21 CFR 866.3040. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KFG?
Across 5 cleared submissions the average was 74 days from receipt to decision (median 21).
Which companies have the most KFG clearances?
Meridian Diagnostics, Inc. (2); Ackrad Laboratories (1); Immuno-Mycologics, Inc. (1); I M, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KFG
- Run a recall and safety report across every KFG manufacturer
- Watch product code KFG for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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