TECHNICON GEN 2 SYS & ANALYTES LD, ALP CK, UN, IN
Device Facts
| Record ID | K850999 |
|---|---|
| Device Name | TECHNICON GEN 2 SYS & ANALYTES LD, ALP CK, UN, IN |
| Applicant | Technicon Instruments Corp. |
| Product Code | JJF · Clinical Chemistry |
| Decision Date | Apr 8, 1985 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.2170 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A micro chemistry analyzer for clinical use is a device intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, preparing filtrates, heating, and measuring color intensity. The distinguishing characteristic of the device is that it requires only micro volume samples obtainable from pediatric patients. This device is intended for use in conjunction with certain materials to measure a variety of analytes.
