FDA product code LDM: Instrumentation, High Pressure Liquid Chromatography
LDM is the FDA product code for instrumentation, high pressure liquid chromatography. It is a Class I device, regulated under 21 CFR 862.2260 and reviewed by the Clinical Toxicology panel. FDA has cleared 19 510(k) submissions under LDM, from 6 different applicants. The average 510(k) review took 59 days (median 42). FDA has posted 1 recall for LDM devices.
Classification
| Field | Value |
|---|---|
| Device name | Instrumentation, High Pressure Liquid Chromatography |
| Device class | Class I |
| Regulation | 21 CFR 862.2260 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every LDM clearance
Top LDM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Millipore Corp. | 7 | 1992-09-11 |
| The Perkin-Elmer Corp. | 5 | 1989-02-02 |
| Hewlett-Packard Co. | 3 | 1983-11-21 |
| Bio-Rad | 2 | 1996-07-08 |
| Waters Corporation | 1 | 1996-07-05 |
1 more applicants have LDM clearances. See the full list in Caduvo.
Most recent LDM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K960392 | Bio-Rad | CDM | 1996-07-08 | 161 |
| K961557 | Waters Corporation | ALLIANCE 2690 SEPARATIONS MODULE | 1996-07-05 | 74 |
| K942451 | Bio-Rad | BIO-RAD CLINICAL DATA MANAGEMENT SYSTEM | 1994-11-10 | 171 |
| K922388 | Millipore Corp. | WATERS(TM) LC MODULE I FOR CLINICAL USE | 1992-09-11 | 114 |
| K920136 | Millipore Corp. | WATERS 717 AUTOSAMPLER | 1992-02-19 | 37 |
Recalls for LDM devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2003-11-17.
Frequently asked questions
What is FDA product code LDM?
LDM is the FDA product code for instrumentation, high pressure liquid chromatography. It is a Class I device, regulated under 21 CFR 862.2260 and reviewed by the Clinical Toxicology panel.
What device class is LDM?
Class I, regulation 21 CFR 862.2260. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LDM?
Across 19 cleared submissions the average was 59 days from receipt to decision (median 42).
Which companies have the most LDM clearances?
Millipore Corp. (7); The Perkin-Elmer Corp. (5); Hewlett-Packard Co. (3); Bio-Rad (2); Waters Corporation (1).
Have LDM devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2003-11-17.
Next steps
- Run an FDA pathway report with predicate devices for product code LDM
- Run a recall and safety report across every LDM manufacturer
- Watch product code LDM 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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