FDA product code CEX: Chromatographic Separation, Lactate Dehydrogenase Isoenzymes
CEX is the FDA product code for chromatographic separation, lactate dehydrogenase isoenzymes. It is a Class II device, regulated under 21 CFR 862.1445 and reviewed by the Clinical Chemistry panel. FDA has cleared 8 510(k) submissions under CEX, from 8 different applicants. The average 510(k) review took 66 days (median 42).
Classification
| Field | Value |
|---|---|
| Device name | Chromatographic Separation, Lactate Dehydrogenase Isoenzymes |
| Device class | Class II |
| Regulation | 21 CFR 862.1445 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every CEX clearance
Top CEX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Data Medical Associates, Inc. | 1 | 1987-09-16 |
| Seragen Diagnostics, Inc. | 1 | 1985-05-10 |
| Berwick Medical Products, Inc. | 1 | 1984-09-28 |
| Helena Laboratories | 1 | 1982-12-22 |
| Harleco Diagnostics | 1 | 1982-07-14 |
3 more applicants have CEX clearances. See the full list in Caduvo.
Most recent CEX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K872891 | Data Medical Associates, Inc. | LACTATE DEHYDROGENASE ISOENZYME 1 | 1987-09-16 | 55 |
| K851521 | Seragen Diagnostics, Inc. | LD-1(IMMUNO) SEPARATION SET | 1985-05-10 | 25 |
| K842018 | Berwick Medical Products, Inc. | ISO-SEP SYSTEM | 1984-09-28 | 133 |
| K821983 | Helena Laboratories | TITAN GEL LDH ISOENZYME KIT | 1982-12-22 | 169 |
| K821879 | Harleco Diagnostics | ULTRACHEM T.P. | 1982-07-14 | 19 |
Recalls for CEX devices
openFDA lists no recalls for product code CEX.
Frequently asked questions
What is FDA product code CEX?
CEX is the FDA product code for chromatographic separation, lactate dehydrogenase isoenzymes. It is a Class II device, regulated under 21 CFR 862.1445 and reviewed by the Clinical Chemistry panel.
What device class is CEX?
Class II, regulation 21 CFR 862.1445. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code CEX?
Across 8 cleared submissions the average was 66 days from receipt to decision (median 42).
Which companies have the most CEX clearances?
Data Medical Associates, Inc. (1); Seragen Diagnostics, Inc. (1); Berwick Medical Products, Inc. (1); Helena Laboratories (1); Harleco Diagnostics (1).
Next steps
- Run an FDA pathway report with predicate devices for product code CEX
- Run a recall and safety report across every CEX manufacturer
- Watch product code CEX 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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