JJK · Oncometer, Plasma, For Clinical Use
Clinical Chemistry · 21 CFR 862.2720 · Class 1
Overview
| Product Code | JJK |
|---|---|
| Device Name | Oncometer, Plasma, For Clinical Use |
| Regulation | 21 CFR 862.2720 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
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.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
Recent Cleared Devices (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K863099 | ABBOTT TESTPACK (TM) ACUTE HEP A CONTROL KIT | Abbott Laboratories | Sep 16, 1986 | SESE |
| K823196 | SPECIAL CONTROL SERUM FOR HDL-CHOLES | Boehringer Mannheim Corp. | Nov 29, 1982 | SESE |
| K802120 | HEPA-SHURE -L | Nuclear Medical Laboratories, Inc. | Oct 20, 1980 | SESE |
| K760975 | WEIL ONCOMETER (IL 186) | Instrumentation Laboratory CO | Jan 12, 1977 | SESE |
Top Applicants
- Abbott Laboratories — 1 clearance
- Boehringer Mannheim Corp. — 1 clearance
- Instrumentation Laboratory CO — 1 clearance
- Nuclear Medical Laboratories, Inc. — 1 clearance
