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510(k) K896206

STATSPIN STATSAMPLER by Statspin Technologies — Product Code JKA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 1989
Date Received
October 26, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubes, Vials, Systems, Serum Separators, Blood Collection
Device Class
Class II
Regulation Number
862.1675
Review Panel
CH
Submission Type

Other clearances by Statspin Technologies

  • K903698 — STATSPIN MICRO-HEMATOCRIT READER FOR 75MM TUBES (September 17, 1990)
  • K893613 — STATSPIN MINI-PLASMA (August 28, 1989)
  • K884807 — LIPOCLEAR LIPEMIA CLEARING REAGENT (January 27, 1989)

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