FDA product code CDM: Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)
CDM is the FDA product code for diazonium colorimetry, urobilinogen (urinary, non-quant.). It is a Class I device, regulated under 21 CFR 862.1785 and reviewed by the Clinical Chemistry panel. FDA has cleared 9 510(k) submissions under CDM, from 8 different applicants. The average 510(k) review took 174 days (median 111). FDA has posted 1 recall for CDM devices.
Classification
| Field | Value |
|---|---|
| Device name | Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) |
| Device class | Class I |
| Regulation | 21 CFR 862.1785 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every CDM clearance
Top CDM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Miles Laboratories, Inc. | 2 | 1985-09-03 |
| Arj Medical, Inc. | 1 | 2006-12-05 |
| Acon Laboratories Co. | 1 | 2006-08-11 |
| Mach Diag. C/O Wichita State University | 1 | 1988-05-31 |
| Wako Chemicals USA, Inc. | 1 | 1988-01-21 |
3 more applicants have CDM clearances. See the full list in Caduvo.
Most recent CDM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K052719 | Arj Medical, Inc. | URITEST 10 URINALYSIS REAGENT STRIPS | 2006-12-05 | 432 |
| K061559 | Acon Laboratories Co. | ACON URINALYSIS REAGENT STRIPS | 2006-08-11 | 67 |
| K880584 | Mach Diag. C/O Wichita State University | URI-CHEM(R) GK,2,3,4C,5CN,6C,7C AND 8C | 1988-05-31 | 111 |
| K873366 | Wako Chemicals USA, Inc. | WAKO(TM) PRETEST 5A | 1988-01-21 | 153 |
| K852611 | Miles Laboratories, Inc. | TEST UROBILINOGEN IN URINE & LEUKOCYTES IN URINE | 1985-09-03 | 76 |
Recalls for CDM devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-06-22.
| Year | Recalls |
|---|---|
| 2018 | 1 |
Frequently asked questions
What is FDA product code CDM?
CDM is the FDA product code for diazonium colorimetry, urobilinogen (urinary, non-quant.). It is a Class I device, regulated under 21 CFR 862.1785 and reviewed by the Clinical Chemistry panel.
What device class is CDM?
Class I, regulation 21 CFR 862.1785. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code CDM?
Across 9 cleared submissions the average was 174 days from receipt to decision (median 111).
Which companies have the most CDM clearances?
Miles Laboratories, Inc. (2); Arj Medical, Inc. (1); Acon Laboratories Co. (1); Mach Diag. C/O Wichita State University (1); Wako Chemicals USA, Inc. (1).
Have CDM devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2018-06-22.
Next steps
- Run an FDA pathway report with predicate devices for product code CDM
- Run a recall and safety report across every CDM manufacturer
- Watch product code CDM 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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