LCHClass I

Tonometer (calibration And Q.c. Of Blood-gas Instruments), Clinical

Clinical Chemistry · 21 CFR 862.1660

MDR events0All time

Recalls2All time

Registered firms3Currently listed

510(k) clearances9All time

Recent MDR events

0 adverse event reports on file

No MDR events on file for this product code.

Event type breakdown

No data available.

Most-reported manufacturers

No data available.

Recalls

2 recall events for this product code

EMD Chemicals Inc
TerminatedMar 26, 2003
Ethanol Standard, 1.5mg Ethanol in 1 mL. Product size configuration: 1 mL glass ampule shipped 10 ampules per case.
The 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.
Z-0683-03 · View FDA record ↗
EMD Chemicals Inc
TerminatedMar 26, 2003
Ethanol Standard, 0.5mg Ethanol in 1 mL. Product size configuration: 1 mL glass ampule shipped 10 ampules per case. Item Number 68988/95
The 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.
Z-0684-03 · View FDA record ↗

Registered firms

3 firms currently registered for this product code

510(k) clearances

9 clearances for this product code