Product code JJK— Clinical Chemistry

FDA has cleared 4 devices under product code JJK between 1977 and 1986, filed by 4 applicant companies. 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.

• 19861 clearance
• 19821 clearance
• 19801 clearance
• 19771 clearance

• Nuclear Medical Laboratories, Inc.1 clearance
• Instrumentation Laboratory CO1 clearance
• Boehringer Mannheim Corp.1 clearance
• Abbott Laboratories1 clearance

• K863099 — ABBOTT TESTPACK (TM) ACUTE HEP A CONTROL KITAbbott Laboratories·1986-09-16
• K823196 — SPECIAL CONTROL SERUM FOR HDL-CHOLESBoehringer Mannheim Corp.·1982-11-29
• K802120 — HEPA-SHURE -LNuclear Medical Laboratories, Inc.·1980-10-20
• K760975 — WEIL ONCOMETER (IL 186)Instrumentation Laboratory CO·1977-01-12