Panels › Clinical Chemistry › Product code LCH · Class 1
Tonometer (Calibration And Q.C. Of Blood-Gas Instruments), Clinical
Regulation 862.1660
0510(k)s in 12 months (9 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in LCH
| Company | 510(k)s | Recalls |
|---|---|---|
| EMD Chemicals Inc | 0 | 2 |
| American Instrument Co. | 1 | 0 |
| Associated Medical Representatives | 1 | 0 |
| Bionostics, Inc. | 1 | 0 |
| Corning Medical & Scientific | 1 | 0 |
| Cryogenic Rare Gas Laboratories, Inc. | 1 | 0 |
| Equilibrated Bio Systems, Inc. | 1 | 0 |
| Linear Tonometers, Inc. | 1 | 0 |
| Medicor USA , Ltd. | 1 | 0 |
| Norco, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 26, 2003 | EMD Chemicals Inc Ethanol Standard, 0.5mg Ethanol in 1 mL. Product size configuration: 1 mL glass ampule shipped 10 ampules per case. Item Number 68988/95 Terminated |
LCH | K990516 |
| Mar 26, 2003 | EMD Chemicals Inc Ethanol Standard, 1.5mg Ethanol in 1 mL. Product size configuration: 1 mL glass ampule shipped 10 ampules per case. Terminated |
LCH | K990516 |
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