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510(k) K884807

LIPOCLEAR LIPEMIA CLEARING REAGENT by Statspin Technologies — Product Code JKA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 1989
Date Received
November 17, 1988
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)
  • K896206 — STATSPIN STATSAMPLER (November 22, 1989)
  • K893613 — STATSPIN MINI-PLASMA (August 28, 1989)

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