EMDS ACETAMINOPHEN CALIBRATOR NO. 67636/95
Device Facts
| Record ID | K882766 |
|---|---|
| Device Name | EMDS ACETAMINOPHEN CALIBRATOR NO. 67636/95 |
| Applicant | Em Diagnostic Systems, Inc. |
| Product Code | DLG · Clinical Chemistry |
| Decision Date | Aug 23, 1988 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.2250 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A gas liquid chromatography system for clinical use is a device intended to separate one or more drugs or compounds from a mixture. Each of the constituents in a vaporized mixture of compounds is separated according to its vapor pressure. The device may include accessories such as columns, gases, column supports, and liquid coating.
