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510(k) K850391

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

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)

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