GENERAL DIAGNOSTICS COAG-A-MATE XC
Device Facts
| Record ID | K852843 |
|---|---|
| Device Name | GENERAL DIAGNOSTICS COAG-A-MATE XC |
| Applicant | Warner-Lambert Co. |
| Product Code | KQC · Hematology |
| Decision Date | Aug 13, 1985 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.1850 |
| Device Class | Class 1 |
Regulatory Classification
Identification
Dye and chemical solution stains for medical purposes are mixtures of synthetic or natural dyes or nondye chemicals in solutions used in staining cells and tissues for diagnostic histopathology, cytopathology, or hematology.
