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510(k) K870511

CHART-TYPE MICRO HEMATOCRIT TUBE READER by Norfolk Scientific, Inc. — Product Code JPI

K870511 is an FDA 510(k) premarket notification submitted by Norfolk Scientific, Inc. for the device "CHART-TYPE MICRO HEMATOCRIT TUBE READER". The FDA issued a decision of Substantially Equivalent on March 16, 1987. The device falls under product code JPI (Device, Hematocrit Measuring), a Class II device regulated under 21 CFR 864.6400. Norfolk Scientific, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 1987
Date Received
February 5, 1987
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.

  • K902028 — STATSPIN ILLUMINATED MICRO-HEMATOCRIT TUBE READER (June 20, 1990)
  • 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)
  • 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)
  • K902028 — STATSPIN ILLUMINATED MICRO-HEMATOCRIT TUBE READER (June 20, 1990)
  • 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