Product code GKM— Hematology

FDA has cleared 4 devices under product code GKM between 1977 and 1988, 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.

• 19881 clearance
• 19861 clearance
• 19841 clearance
• 19771 clearance

• Scientific Products1 clearance
• Instrumentation Laboratory CO1 clearance
• Future Impex Corp.1 clearance
• Coulter Electronics, Inc.1 clearance

• K874188 — COULTER IMMUNOPREP LEUKOCYTE/Q-PREP IMMUNO WRK STACoulter Electronics, Inc.·1988-01-19
• K854685 — DIGITAL-9 KEY LEUCOCYTE COUNTERFuture Impex Corp.·1986-04-04
• K841026 — MANUAL BLOOD CELL COUNTING DEVICEInstrumentation Laboratory CO·1984-04-04
• K771580 — TEKTALLY IIScientific Products·1977-09-02