FDA product code ICL: Carbol Fuchsin
ICL is the FDA product code for carbol fuchsin. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel. FDA has cleared 4 510(k) submissions under ICL, from 4 different applicants. The average 510(k) review took 28 days (median 28).
Classification
| Field | Value |
|---|---|
| Device name | Carbol Fuchsin |
| 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 ICL clearance
Top ICL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Alpha-Tec Systems, Inc. | 1 | 1989-01-24 |
| E K Ind., Inc. | 1 | 1984-09-11 |
| Laboratory Products, Inc. | 1 | 1979-12-18 |
| Harleco | 1 | 1977-08-22 |
Most recent ICL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K890148 | Alpha-Tec Systems, Inc. | ATS TB RAPID STAIN SET PRODUCT #034-45 | 1989-01-24 | 11 |
| K842933 | E K Ind., Inc. | CARBOL-FUCHSIN, ZIEHL-NEEDSEN | 1984-09-11 | 48 |
| K792483 | Laboratory Products, Inc. | STAINS, COUNTERSTAINS & GEN. PURPOSE | 1979-12-18 | 29 |
| K771390 | Harleco | HISTOCHEMICAL AFB DEMONSTRATION | 1977-08-22 | 26 |
Recalls for ICL devices
openFDA lists no recalls for product code ICL.
Frequently asked questions
What is FDA product code ICL?
ICL is the FDA product code for carbol fuchsin. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel.
What device class is ICL?
Class I, regulation 21 CFR 864.1850. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code ICL?
Across 4 cleared submissions the average was 28 days from receipt to decision (median 28).
Which companies have the most ICL clearances?
Alpha-Tec Systems, Inc. (1); E K Ind., Inc. (1); Laboratory Products, Inc. (1); Harleco (1).
Next steps
- Run an FDA pathway report with predicate devices for product code ICL
- Run a recall and safety report across every ICL manufacturer
- Watch product code ICL 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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