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Tonometer (Calibration And Q.C. Of Blood-Gas Instruments), Clinical

FDA product code LCH · Class 1 · Clinical Chemistry

1
Registered devices
0
Adverse events
2
Recalls
9
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2002-12-13EMD Chemicals IncThe Ethanol Standard is OOS on the low end. The results were 0.44 mg/mL while the specification is 0.48-0.52 mg/mL.
2002-12-13EMD Chemicals IncThe Ethanol Standard is OOS on the high end. The results were 1.58 mg/mL while the specification is 1.477-1.538 mg/mL.

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