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510(k) K903698

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

K903698 is an FDA 510(k) premarket notification submitted by Statspin Technologies for the device "STATSPIN MICRO-HEMATOCRIT READER FOR 75MM TUBES". The FDA issued a decision of Substantially Equivalent on September 17, 1990. The device falls under product code JPI (Device, Hematocrit Measuring), a Class II device regulated under 21 CFR 864.6400. Statspin Technologies has at least 3 other 510(k) clearances on record.

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)

Other clearances for product code JPI

  • K183680 — i-STAT CHEM8+ cartridge with the i-STAT 1 System (February 28, 2020)
  • K163342 — i-STAT Hematocrit test with i-STAT Alinity System (August 22, 2017)
  • 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)
  • K852516 — CENTIFUGE, HEMATOCRIT & MICROSEDIMENTATION COMBINE (July 15, 1985)
  • K852482 — MICROSPIN MINICENTRIFUGE ITEM NO. 65204/94 (July 15, 1985)
  • K850391 — PLASMA EXTRACTION SYSTEM (May 10, 1985)
  • K840767 — HAEMOFUGE A. BIOFUGE A. & B (April 17, 1984)

FDA data resources