FDA product code NEO: System, Test, Osteocalcin
NEO is the FDA product code for system, test, osteocalcin. It is a Class II device, regulated under 21 CFR 862.1050 and reviewed by the Clinical Chemistry panel. FDA has cleared 2 510(k) submissions under NEO, from 2 different applicants. The average 510(k) review took 144 days (median 144). FDA has posted 2 recalls for NEO devices.
Classification
| Field | Value |
|---|---|
| Device name | System, Test, Osteocalcin |
| Device class | Class II |
| Regulation | 21 CFR 862.1050 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every NEO clearance
Top NEO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Roche Diagnostics Corp. | 1 | 2005-09-08 |
| Osteometer Biotech A/S | 1 | 2001-05-16 |
Most recent NEO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K051297 | Roche Diagnostics Corp. | ELECSYS N-MID OSTEOCALCIN, ELECSYS OSTEOCALCIN CALSET, ELECSYS OSTEOCALCIN CALCHECK | 2005-09-08 | 113 |
| K003609 | Osteometer Biotech A/S | N-MID OSTEOCALCIN ONE STEP ELISA MODEL 30SC4000 | 2001-05-16 | 175 |
Recalls for NEO devices
2 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2012-08-10.
Frequently asked questions
What is FDA product code NEO?
NEO is the FDA product code for system, test, osteocalcin. It is a Class II device, regulated under 21 CFR 862.1050 and reviewed by the Clinical Chemistry panel.
What device class is NEO?
Class II, regulation 21 CFR 862.1050. Typical premarket route: 510(k).
How long does a 510(k) take for product code NEO?
Across 2 cleared submissions the average was 144 days from receipt to decision (median 144).
Which companies have the most NEO clearances?
Roche Diagnostics Corp. (1); Osteometer Biotech A/S (1).
Have NEO devices been recalled?
Yes: 2 product recalls across 1 recall events; the most recent began 2012-08-10.
Next steps
- Run an FDA pathway report with predicate devices for product code NEO
- Run a recall and safety report across every NEO manufacturer
- Watch product code NEO 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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