ABBOTT TESTPACK (TM) ACUTE HEP A CONTROL KIT
Device Facts
| Record ID | K863099 |
|---|---|
| Device Name | ABBOTT TESTPACK (TM) ACUTE HEP A CONTROL KIT |
| Applicant | Abbott Laboratories |
| Product Code | JJK · Clinical Chemistry |
| Decision Date | Sep 16, 1986 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.2720 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A plasma oncometer for clinical use is a device intended to measure plasma oncotic pressure, which is that portion of the total plasma osmotic pressure contributed by protein and other molecules too large to pass through a specified semipermeable membrane. Because variations in plasma oncotic pressure are indications of certain disorders, measurements of the variations are useful in the diagnosis and treatment of these disorders.
