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510(k) K831558

E-Z PREP by Coulter Electronics, Inc. — Product Code GKJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 1983
Date Received
May 16, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spinner, Slide, Automated
Device Class
Class I
Regulation Number
864.5850
Review Panel
HE
Submission Type

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Other clearances for product code GKJ

  • K854962 — MICRO-MAT SYSTEM (December 23, 1985)
  • K854121 — MICRO-MAT SYSTEM (October 31, 1985)
  • K811534 — HEMASPINNER (August 18, 1981)
  • K771898 — AUTOMATED SLIDE SPINNER (October 18, 1977)
  • K760007 — BLOOD-SMEARING INSTRUMENT (MINIPREP TM) (September 3, 1976)