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510(k) K874188

COULTER IMMUNOPREP LEUKOCYTE/Q-PREP IMMUNO WRK STA by Coulter Electronics, Inc. — Product Code GKM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 19, 1988
Date Received
October 14, 1987
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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Other clearances for product code GKM

  • K854685 — DIGITAL-9 KEY LEUCOCYTE COUNTER (April 4, 1986)
  • K841026 — MANUAL BLOOD CELL COUNTING DEVICE (April 4, 1984)
  • K771580 — TEKTALLY II (September 2, 1977)