FDA product code KFH: Antiserum, Positive Control, Blastomyces Dermatitidis
KFH is the FDA product code for antiserum, positive control, blastomyces dermatitidis. It is a Class II device, regulated under 21 CFR 866.3060 and reviewed by the Microbiology panel. FDA has cleared 4 510(k) submissions under KFH, from 3 different applicants. The average 510(k) review took 28 days (median 21).
Classification
| Field | Value |
|---|---|
| Device name | Antiserum, Positive Control, Blastomyces Dermatitidis |
| Device class | Class II |
| Regulation | 21 CFR 866.3060 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every KFH clearance
Top KFH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Meridian Diagnostics, Inc. | 2 | 1980-01-17 |
| Immuno-Mycologics, Inc. | 1 | 1988-02-24 |
| I M, Inc. | 1 | 1976-11-01 |
Most recent KFH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K880029 | Immuno-Mycologics, Inc. | EXO-ANTIGEN IDENTIFICATION SYSTEM CAT.# EX1001 | 1988-02-24 | 50 |
| K792685 | Meridian Diagnostics, Inc. | BLASTOMYCES DERMATITIDIS, ANTISERUM | 1980-01-17 | 21 |
| K792681 | Meridian Diagnostics, Inc. | BLASTOMYCES DERMATITIDIS POS/CONTROL | 1980-01-17 | 21 |
| K760833 | I M, Inc. | ANTI-BLASTOMYCES CONTROL SERUM (YEAST) | 1976-11-01 | 19 |
Recalls for KFH devices
openFDA lists no recalls for product code KFH.
Frequently asked questions
What is FDA product code KFH?
KFH is the FDA product code for antiserum, positive control, blastomyces dermatitidis. It is a Class II device, regulated under 21 CFR 866.3060 and reviewed by the Microbiology panel.
What device class is KFH?
Class II, regulation 21 CFR 866.3060. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KFH?
Across 4 cleared submissions the average was 28 days from receipt to decision (median 21).
Which companies have the most KFH clearances?
Meridian Diagnostics, Inc. (2); Immuno-Mycologics, Inc. (1); I M, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KFH
- Run a recall and safety report across every KFH manufacturer
- Watch product code KFH 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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