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510(k) K831318

COMPUR* M1100 HEMATRCRIT SYSTEM by Worthington Diagnostic Systems — Product Code JPI

K831318 is an FDA 510(k) premarket notification submitted by Worthington Diagnostic Systems for the device "COMPUR* M1100 HEMATRCRIT SYSTEM". The FDA issued a decision of Substantially Equivalent on June 8, 1983. The device falls under product code JPI (Device, Hematocrit Measuring), a Class II device regulated under 21 CFR 864.6400. Worthington Diagnostic Systems has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 8, 1983
Date Received
April 22, 1983
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 Worthington Diagnostic Systems

  • K833708 — COMPUR* M1000 HEMOGLOBIN & ERYTHROCYTE (January 4, 1984)
  • K832427 — EASYTOUCH TROMBOPLASTIN REAGENT (October 14, 1983)
  • K832748 — COMPUR* EASYTOUCH TOTAL BILIRUBIN (October 14, 1983)
  • K832749 — EASYTOUCH BUN REAGENT SET (October 14, 1983)
  • K832785 — COMPUR* EASY TOUCH URIC ACID REAGENT (October 14, 1983)
  • K832750 — EASYTOUCH HEMOGLOBIN REAGENT (September 26, 1983)
  • K832426 — EASYTOUCH TRIGLYCERIDES REAGENT SET (September 12, 1983)
  • K831477 — DEMAND ANALYZER SYSTEM (June 17, 1983)
  • K831227 — COMPUR EASY TOUCH CHEMISTRY ANALYZER- (June 2, 1983)
  • K831102 — TIA-IGA REAGENT & CALIBRATOR SETS (April 27, 1983)

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)
  • 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)

FDA data resources