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510(k) K850391

PLASMA EXTRACTION SYSTEM by Hans J. Brouwers & Assoc. — Product Code JPI

K850391 is an FDA 510(k) premarket notification submitted by Hans J. Brouwers & Assoc. for the device "PLASMA EXTRACTION SYSTEM". The FDA issued a decision of Substantially Equivalent on May 10, 1985. The device falls under product code JPI (Device, Hematocrit Measuring), a Class II device regulated under 21 CFR 864.6400. Hans J. Brouwers & Assoc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 10, 1985
Date Received
February 1, 1985
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 Hans J. Brouwers & Assoc.

  • K850390 — CHOLESTEROL TEST SYSTEM (July 9, 1985)

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)
  • 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)
  • K840767 — HAEMOFUGE A. BIOFUGE A. & B (April 17, 1984)

FDA data resources