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510(k) K903698

STATSPIN MICRO-HEMATOCRIT READER FOR 75MM TUBES by Statspin Technologies — Product Code JPI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 17, 1990
Date Received
August 15, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Hematocrit Measuring
Device Class
Class II
Regulation Number
864.6400
Review Panel
HE
Submission Type

Other clearances by Statspin Technologies

  • K896206 — STATSPIN STATSAMPLER (November 22, 1989)
  • K893613 — STATSPIN MINI-PLASMA (August 28, 1989)
  • K884807 — LIPOCLEAR LIPEMIA CLEARING REAGENT (January 27, 1989)

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  • K950942 — CRIT-LINE HEMATOCRIT ALERT (March 14, 1995)
  • K924167 — CRIT-LINE (May 7, 1993)
  • K902028 — STATSPIN ILLUMINATED MICRO-HEMATOCRIT TUBE READER (June 20, 1990)
  • K870511 — CHART-TYPE MICRO HEMATOCRIT TUBE READER (March 16, 1987)
  • K852482 — MICROSPIN MINICENTRIFUGE ITEM NO. 65204/94 (July 15, 1985)
  • K852516 — CENTIFUGE, HEMATOCRIT & MICROSEDIMENTATION COMBINE (July 15, 1985)
  • K850391 — PLASMA EXTRACTION SYSTEM (May 10, 1985)
  • K840767 — HAEMOFUGE A. BIOFUGE A. & B (April 17, 1984)