Product code JJL— Clinical Chemistry

COULTER VISCOMETER II

Classification name: Plasma Viscometer For Clinical Use
Device class: Class 1
Regulation: 21 CFR 862.2920
Advisory panel: Clinical Chemistry
Total cleared: 1
First cleared: 1988-09-19
Most recent: 1988-09-19

Market context for product code JJL

FDA has cleared 1 device under product code JJL, all in 1988, filed by 1 applicant company. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Top applicants under product code JJL

Coulter Electronics, Inc.1 clearance

Recent clearances under product code JJL

K883503 — COULTER VISCOMETER IICoulter Electronics, Inc.·1988-09-19

Data sourced from openFDA. This site is unofficial and independent of the FDA.