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510(k) K852482

MICROSPIN MINICENTRIFUGE ITEM NO. 65204/94 by Em Diagnostic Systems, Inc. — Product Code JPI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 15, 1985
Date Received
June 11, 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 Em Diagnostic Systems, Inc.

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  • K935179 — EMDS ALBUMIN (ALB) TEST (December 17, 1993)
  • K935178 — EMDS PHOSPHOROUS (PHOS) TEST (December 17, 1993)
  • K935136 — CHOLESTEROL (CHOL) TEST ITEM NO. 65410 (December 16, 1993)
  • K935175 — LACTATE DEHYDROGENASE (LD) (December 16, 1993)
  • K935177 — GAMMA-GLUTAMYL TRANSFERASE (GGT) TEST (December 16, 1993)
  • K935174 — TOTAL PROTEIN TEST (TPRO) (December 16, 1993)
  • K935176 — IRON TEST (December 16, 1993)
  • K935182 — EMDS ALKANINE PHOSPHATASE (ALP) TEST (December 9, 1993)

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