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510(k) K854962

MICRO-MAT SYSTEM by Ulster Scientific, Inc. — Product Code GKJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 1985
Date Received
December 11, 1985
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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  • K885340 — AIR DISPLACEMENT PIPETTE (February 14, 1989)
  • K875354 — UNISTEP CAPILLARY BLOOD COLLECTION SYSTEM (February 17, 1988)
  • K871571 — NEUROTIPS(TM) (June 18, 1987)
  • K871076 — WINPETTE (March 23, 1987)
  • K870078 — ACCUPEN(R) (March 17, 1987)

Other clearances for product code GKJ

  • K854121 — MICRO-MAT SYSTEM (October 31, 1985)
  • K831558 — E-Z PREP (June 16, 1983)
  • K811534 — HEMASPINNER (August 18, 1981)
  • K771898 — AUTOMATED SLIDE SPINNER (October 18, 1977)
  • K760007 — BLOOD-SMEARING INSTRUMENT (MINIPREP TM) (September 3, 1976)