FDA product code CFG: Oil Emulsion/Thymolphthalein (Titrimetric), Lipase
CFG is the FDA product code for oil emulsion/thymolphthalein (titrimetric), lipase. It is a Class I device, regulated under 21 CFR 862.1465 and reviewed by the Clinical Chemistry panel. FDA has cleared 2 510(k) submissions under CFG, from 2 different applicants. The average 510(k) review took 26 days (median 26).
Classification
| Field | Value |
|---|---|
| Device name | Oil Emulsion/Thymolphthalein (Titrimetric), Lipase |
| Device class | Class I |
| Regulation | 21 CFR 862.1465 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every CFG clearance
Top CFG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sterling Diagnostics, Inc. | 1 | 1986-03-14 |
| The Dow Chemical Co. | 1 | 1980-04-02 |
Most recent CFG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K860554 | Sterling Diagnostics, Inc. | SERUM LIPASE REAGENT SET (TURBIDIMETRIC) | 1986-03-14 | 28 |
| K800550 | The Dow Chemical Co. | LIPASE DETERMINATION | 1980-04-02 | 23 |
Recalls for CFG devices
openFDA lists no recalls for product code CFG.
Frequently asked questions
What is FDA product code CFG?
CFG is the FDA product code for oil emulsion/thymolphthalein (titrimetric), lipase. It is a Class I device, regulated under 21 CFR 862.1465 and reviewed by the Clinical Chemistry panel.
What device class is CFG?
Class I, regulation 21 CFR 862.1465. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code CFG?
Across 2 cleared submissions the average was 26 days from receipt to decision (median 26).
Which companies have the most CFG clearances?
Sterling Diagnostics, Inc. (1); The Dow Chemical Co. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code CFG
- Run a recall and safety report across every CFG manufacturer
- Watch product code CFG 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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