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510(k) K904675

QBC SYSTEM MCHC by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code JPJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 2, 1990
Date Received
October 12, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Red-Cell Indices, Calculated
Device Class
Class II
Regulation Number
864.5300
Review Panel
HE
Submission Type

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Other clearances for product code JPJ

  • K780946 — ROYCO MODEL 970 HEMATOLOGY DATA ANALYZER (July 27, 1978)
  • K761304 — JTB 700 HEMATOLOGY ANALYZER (February 1, 1977)