510(k) K841026

MANUAL BLOOD CELL COUNTING DEVICE by Instrumentation Laboratory CO — Product Code GKM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 1984
Date Received
March 12, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hand-Tally, Differential
Device Class
Class I
Regulation Number
864.6160
Review Panel
HE
Submission Type