FDA product code CEO: Phosphomolybdate (Colorimetric), Inorganic Phosphorus
CEO is the FDA product code for phosphomolybdate (colorimetric), inorganic phosphorus. It is a Class I device, regulated under 21 CFR 862.1580 and reviewed by the Clinical Chemistry panel. FDA has cleared 105 510(k) submissions under CEO, from 76 different applicants. The average 510(k) review took 54 days (median 39). FDA has posted 8 recalls for CEO devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Phosphomolybdate (Colorimetric), Inorganic Phosphorus |
| Device class | Class I |
| Regulation | 21 CFR 862.1580 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every CEO clearance
Top CEO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Em Diagnostic Systems, Inc. | 10 | 1993-12-17 |
| Harleco | 5 | 1977-12-06 |
| Abbott Laboratories | 4 | 1998-06-16 |
| American Research Products Co. | 4 | 1990-05-31 |
| Olympus Corp. | 3 | 1993-09-08 |
71 more applicants have CEO clearances. See the full list in Caduvo.
Most recent CEO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K100263 | Seppim S.A.S. | ELITECH CLINICAL SYSTEMS PHOSPHORUS, URIC ACID MONO SL AND UREA UV SL REAGENTS | 2011-05-06 | 463 |
| K072141 | Alfa Wassermann Diagnostic Technologies, Inc. | S40 CLINICAL ANALYZER, S TEST IP, S TEST UA | 2008-06-24 | 327 |
| K041643 | Beckman Coulter, Inc. | SYNCHRON SYSTEMS PHOSPHORUS (PHS) REAGENT | 2004-08-18 | 62 |
| K030015 | Elan Diagnostics | ATAC PAK PHOSPHORUS REAGENT | 2003-03-07 | 64 |
| K022312 | Abaxis, Inc. | PICCOLO PHOSPHORUS TEST SYSTEM | 2002-09-05 | 50 |
Recalls for CEO devices
8 product recalls in 8 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2025-09-03.
| Year | Recalls |
|---|---|
| 2025 | 2 |
Frequently asked questions
What is FDA product code CEO?
CEO is the FDA product code for phosphomolybdate (colorimetric), inorganic phosphorus. It is a Class I device, regulated under 21 CFR 862.1580 and reviewed by the Clinical Chemistry panel.
What device class is CEO?
Class I, regulation 21 CFR 862.1580. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code CEO?
Across 105 cleared submissions the average was 54 days from receipt to decision (median 39).
Which companies have the most CEO clearances?
Em Diagnostic Systems, Inc. (10); Harleco (5); Abbott Laboratories (4); American Research Products Co. (4); Olympus Corp. (3).
Have CEO devices been recalled?
Yes: 8 product recalls across 8 recall events; the most recent began 2025-09-03.
Next steps
- Run an FDA pathway report with predicate devices for product code CEO
- Run a recall and safety report across every CEO manufacturer
- Watch product code CEO 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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