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510(k) K771580

TEKTALLY II by Scientific Products — Product Code GKM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 2, 1977
Date Received
August 18, 1977
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

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  • K841026 — MANUAL BLOOD CELL COUNTING DEVICE (April 4, 1984)