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510(k) K902028

STATSPIN ILLUMINATED MICRO-HEMATOCRIT TUBE READER by Norfolk Scientific, Inc. — Product Code JPI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 1990
Date Received
May 4, 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 Norfolk Scientific, Inc.

  • K890669 — STATSPIN HDL-CHOLESTEROL PRECIPITATING MICRO TUBE (March 8, 1989)
  • K883185 — SAFECRIT PLASTIC MICROHEMATOCRIT TUBES (August 18, 1988)
  • K881254 — STATSPIN DISPOSABLE ROTOR, PRODUCT #RD01 (April 5, 1988)
  • K870511 — CHART-TYPE MICRO HEMATOCRIT TUBE READER (March 16, 1987)
  • K864974 — GENERAL PURPOSE CENTRIFUGE (January 9, 1987)
  • K860172 — QWIKSPIN (TM) (February 11, 1986)

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)
  • K903698 — STATSPIN MICRO-HEMATOCRIT READER FOR 75MM TUBES (September 17, 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)