JJK
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Oncometer, Plasma, For Clinical Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2720
- Medical specialty
- Clinical Chemistry
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| ABBOTT TESTPACK (TM) ACUTE HEP A CONTROL KIT (K863099) | Abbott Laboratories | 1986-09-16 |
| SPECIAL CONTROL SERUM FOR HDL-CHOLES (K823196) | Boehringer Mannheim Corp. | 1982-11-29 |
| HEPA-SHURE -L (K802120) | Nuclear Medical Laboratories, Inc. | 1980-10-20 |
| WEIL ONCOMETER (IL 186) (K760975) | Instrumentation Laboratory CO | 1977-01-12 |
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Every clearance here is in the API, with alerts when new ones post.