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510(k) K950942

CRIT-LINE HEMATOCRIT ALERT by In-Line Diagnostics Corp. — Product Code JPI

K950942 is an FDA 510(k) premarket notification submitted by In-Line Diagnostics Corp. for the device "CRIT-LINE HEMATOCRIT ALERT". The FDA issued a decision of Substantially Equivalent on March 14, 1995. The device falls under product code JPI (Device, Hematocrit Measuring), a Class II device regulated under 21 CFR 864.6400. In-Line Diagnostics Corp. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 14, 1995
Date Received
February 15, 1995
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 In-Line Diagnostics Corp.

  • K001763 — CRIT-LINE MONITOR III (CLM III) (December 20, 2000)
  • K992227 — CRIT-LINE MONITOR III (CLM III) (July 30, 1999)
  • K983551 — CRIT-SCAN II MONITOR (May 27, 1999)
  • K982412 — MODIFICATION OF CRIT-LINE MONITOR III (CLM III) (October 9, 1998)
  • K972470 — CRIT-LINE MONITOR (CLMIII) (December 11, 1997)
  • K953875 — CRIT-LINE HEMATOCRIT ALERT (MODIFICATION) (July 23, 1996)
  • K935958 — CRIT-LINE BLOOD CHAMBER WITH E-BEAM (January 19, 1995)

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)
  • 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)
  • K850391 — PLASMA EXTRACTION SYSTEM (May 10, 1985)
  • K840767 — HAEMOFUGE A. BIOFUGE A. & B (April 17, 1984)

FDA data resources