Product Code: JJK
FDA class 1
21 CFR 862.2720
Oncometer, Plasma, For Clinical Use
Clinical Chemistry
This device is a plasma oncometer used in clinical chemistry to measure the colloid oncotic pressure of plasma, which reflects the protein content of blood and is relevant to assessing conditions such as hypoalbuminemia, edema, and fluid balance disorders. It is classified as FDA Class 1 and requires only general controls with no premarket notification. The product code is JJK, regulated under 21 CFR 862.2720, within the Clinical Chemistry medical specialty.
510(k)s
4
FEI Numbers
0
Registration Numbers
0
Unique Applicants
4
Years Active
10
Basic Information
- Product Code
- JJK
- Device Class
- FDA class 1
- Regulation Number
- 862.2720
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 4
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K863099 | ABBOTT TESTPACK (TM) ACUTE HEP A CONTROL KIT | Sep 16, 1986 | Substantially Equivalent | Abbott Laboratories |
| K823196 | SPECIAL CONTROL SERUM FOR HDL-CHOLES | Nov 29, 1982 | Substantially Equivalent | Boehringer Mannheim Corp. |
| K802120 | HEPA-SHURE -L | Oct 20, 1980 | Substantially Equivalent | Nuclear Medical Laboratories, Inc. |
| K760975 | WEIL ONCOMETER (IL 186) | Jan 12, 1977 | Substantially Equivalent | Instrumentation Laboratory CO |