FDA product code CED: 5-Amp-Phosphate Release (Colorimetric Test), 5'-Nucleotidase
CED is the FDA product code for 5-amp-phosphate release (colorimetric test), 5'-nucleotidase. It is a Class I device, regulated under 21 CFR 862.1520 and reviewed by the Clinical Chemistry panel. FDA has cleared 9 510(k) submissions under CED, from 8 different applicants. The average 510(k) review took 42 days (median 30).
Classification
| Field | Value |
|---|---|
| Device name | 5-Amp-Phosphate Release (Colorimetric Test), 5'-Nucleotidase |
| Device class | Class I |
| Regulation | 21 CFR 862.1520 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every CED clearance
Top CED applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Union Carbide Corp. | 2 | 1980-10-31 |
| Em Diagnostic Systems, Inc. | 1 | 1989-08-31 |
| Eastman Kodak Company | 1 | 1984-03-22 |
| Btc Diagnostics, Inc. | 1 | 1984-01-30 |
| American Monitor Corp. | 1 | 1982-04-15 |
3 more applicants have CED clearances. See the full list in Caduvo.
Most recent CED clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K894288 | Em Diagnostic Systems, Inc. | PHOSPHORUS TEST ITEM NUMBER 65416 | 1989-08-31 | 69 |
| K840151 | Eastman Kodak Company | EKTACHEM CLINICAL CHEM. SLIDES | 1984-03-22 | 69 |
| K833710 | Btc Diagnostics, Inc. | BTC URINE LH ASSAY | 1984-01-30 | 102 |
| K820832 | American Monitor Corp. | PHOSPHORUS IL | 1982-04-15 | 20 |
| K812670 | Sandare Chemical Co., Inc. | SANDARE FAST 340 PHOSPHORUS PROCEDURE | 1981-10-02 | 11 |
Recalls for CED devices
openFDA lists no recalls for product code CED.
Frequently asked questions
What is FDA product code CED?
CED is the FDA product code for 5-amp-phosphate release (colorimetric test), 5'-nucleotidase. It is a Class I device, regulated under 21 CFR 862.1520 and reviewed by the Clinical Chemistry panel.
What device class is CED?
Class I, regulation 21 CFR 862.1520. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code CED?
Across 9 cleared submissions the average was 42 days from receipt to decision (median 30).
Which companies have the most CED clearances?
Union Carbide Corp. (2); Em Diagnostic Systems, Inc. (1); Eastman Kodak Company (1); Btc Diagnostics, Inc. (1); American Monitor Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code CED
- Run a recall and safety report across every CED manufacturer
- Watch product code CED 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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