FDA product code KFC: Methylene Blue, Tissue Stain
KFC is the FDA product code for methylene blue, tissue stain. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel. FDA has cleared 7 510(k) submissions under KFC, from 6 different applicants. The average 510(k) review took 50 days (median 48).
Classification
| Field | Value |
|---|---|
| Device name | Methylene Blue, Tissue Stain |
| Device class | Class I |
| Regulation | 21 CFR 864.1850 |
| Review panel | PA — Pathology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every KFC clearance
Top KFC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| E K Ind., Inc. | 2 | 1984-09-11 |
| Sigma Diagnostics, Inc. | 1 | 1988-02-09 |
| Difco Laboratories, Inc. | 1 | 1984-10-30 |
| Reagent Laboratory, Inc. | 1 | 1984-09-11 |
| Flaitron Laboratories, Inc. | 1 | 1983-07-18 |
1 more applicants have KFC clearances. See the full list in Caduvo.
Most recent KFC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K875310 | Sigma Diagnostics, Inc. | RETICULOCYTE STAIN | 1988-02-09 | 42 |
| K843919 | Difco Laboratories, Inc. | SPOTTEST LOEFFLER METHYLENE BLUE STAIN | 1984-10-30 | 25 |
| K842785 | Reagent Laboratory, Inc. | STAIN, METHYLENE BLUE-EOSIN | 1984-09-11 | 71 |
| K842926 | E K Ind., Inc. | METHYLENE BLUE STAIN, LOEFFLER | 1984-09-11 | 48 |
| K842743 | E K Ind., Inc. | NEW METHYLENE BLUE N | 1984-08-12 | 30 |
Recalls for KFC devices
openFDA lists no recalls for product code KFC.
Frequently asked questions
What is FDA product code KFC?
KFC is the FDA product code for methylene blue, tissue stain. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel.
What device class is KFC?
Class I, regulation 21 CFR 864.1850. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KFC?
Across 7 cleared submissions the average was 50 days from receipt to decision (median 48).
Which companies have the most KFC clearances?
E K Ind., Inc. (2); Sigma Diagnostics, Inc. (1); Difco Laboratories, Inc. (1); Reagent Laboratory, Inc. (1); Flaitron Laboratories, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KFC
- Run a recall and safety report across every KFC manufacturer
- Watch product code KFC 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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