JJK — Oncometer, Plasma, For Clinical Use Class I
FDA product code JJK covers "Oncometer, Plasma, For Clinical Use", a Class I medical device regulated under 21 CFR 862.2720. Submissions are reviewed by the Clinical Chemistry panel. At least 4 recent 510(k) clearances have been granted under this product code.
Classification details
- Product Code
- JJK
- Device Class
- Class I
- Regulation Number
- 862.2720
- Submission Type
- 510(k) Exempt
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K863099 | Abbott Laboratories | ABBOTT TESTPACK (TM) ACUTE HEP A CONTROL KIT | Sep 16, 1986 |
| K823196 | Boehringer Mannheim | SPECIAL CONTROL SERUM FOR HDL-CHOLES | Nov 29, 1982 |
| K802120 | Nuclear Medical Laboratories | HEPA-SHURE -L | Oct 20, 1980 |
| K760975 | Instrumentation Laboratory | WEIL ONCOMETER (IL 186) | Jan 12, 1977 |