FDA product code LCH: Tonometer (Calibration And Q.C. Of Blood-Gas Instruments), Clinical
LCH is the FDA product code for tonometer (calibration and q.c. of blood-gas instruments), clinical. It is a Class I device, regulated under 21 CFR 862.1660 and reviewed by the Clinical Chemistry panel. FDA has cleared 9 510(k) submissions under LCH, from 9 different applicants. The average 510(k) review took 52 days (median 37). FDA has posted 2 recalls for LCH devices.
Classification
| Field | Value |
|---|---|
| Device name | Tonometer (Calibration And Q.C. Of Blood-Gas Instruments), Clinical |
| Device class | Class I |
| Regulation | 21 CFR 862.1660 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every LCH clearance
Top LCH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bionostics, Inc. | 1 | 1992-06-26 |
| Norco, Inc. | 1 | 1990-11-01 |
| Cryogenic Rare Gas Laboratories, Inc. | 1 | 1990-04-25 |
| Associated Medical Representatives | 1 | 1986-11-24 |
| Linear Tonometers, Inc. | 1 | 1984-05-22 |
4 more applicants have LCH clearances. See the full list in Caduvo.
Most recent LCH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K922386 | Bionostics, Inc. | RNA MEDICAL TONOMETER | 1992-06-26 | 37 |
| K904163 | Norco, Inc. | CLINICAL BLOOD GAS MIXTURES | 1990-11-01 | 51 |
| K900819 | Cryogenic Rare Gas Laboratories, Inc. | BLOOD GAS CALIBRATION STANDARD | 1990-04-25 | 63 |
| K862958 | Associated Medical Representatives | AMR RESEARCH TONOMETER | 1986-11-24 | 111 |
| K841089 | Linear Tonometers, Inc. | LINEAR CLOUD TONOMETER | 1984-05-22 | 70 |
Recalls for LCH devices
2 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2002-12-13.
Frequently asked questions
What is FDA product code LCH?
LCH is the FDA product code for tonometer (calibration and q.c. of blood-gas instruments), clinical. It is a Class I device, regulated under 21 CFR 862.1660 and reviewed by the Clinical Chemistry panel.
What device class is LCH?
Class I, regulation 21 CFR 862.1660. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LCH?
Across 9 cleared submissions the average was 52 days from receipt to decision (median 37).
Which companies have the most LCH clearances?
Bionostics, Inc. (1); Norco, Inc. (1); Cryogenic Rare Gas Laboratories, Inc. (1); Associated Medical Representatives (1); Linear Tonometers, Inc. (1).
Have LCH devices been recalled?
Yes: 2 product recalls across 1 recall events; the most recent began 2002-12-13.
Next steps
- Run an FDA pathway report with predicate devices for product code LCH
- Run a recall and safety report across every LCH manufacturer
- Watch product code LCH 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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