Product code JBX— Hematology
ARACHIDONIC ACID
- Classification name
- Aggregrometer, Platelet
- Device class
- Class 2
- Regulation
- 21 CFR 864.6675
- Advisory panel
- Hematology
- Total cleared
- 12
- First cleared
- Most recent
Market context for product code JBX
FDA has cleared devices under product code JBX between 1976 and 1993, filed by 7 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 1993
- 1991
- 1988
- 1986
- 1985
- 1983
- 1982
- 1981
- 1978
- 1976
Top applicants under product code JBX
Recent clearances under product code JBX
- K932566 — AGGRO/LINK CONTROL SOFTWARE
- K912774 — ARACHIDONIC ACID
- K881829 — PAT PLATELET AGGREGATION TEST
- K862775 — ASSERACHROM B-TG KIT
- K851025 — AGGRO/LINK COMPUTER INTERFACE
- K850592 — PLATELET AGGREGATION REAGENT
- K832929 — RISTOCETIN PLATELET AGGREGA-REAGENT TEST
- K830749 — PLATELET AGGREGOMETER
- K821005 — PLATELET AGGREGATION PROFILER #PAP-4
- K811290 — ARACHIDONIC ACID
- K781710 — BUFFER, COLLAGEN REAGENT AND DILUENT
- K760159 — AGGREGOMETER, DUAL CHANNEL PLATELET
Data sourced from openFDA. This site is unofficial and independent of the FDA.