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510(k) K823930

HEMATOLOGY QUALITY CONTROL MIXTURE by Fisher Scientific Co., LLC — Product Code GJP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 1, 1983
Date Received
December 29, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Control, Platelet
Device Class
Class II
Regulation Number
864.8625
Review Panel
HE
Submission Type

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Other clearances for product code GJP

  • K880608 — MSI-PC (March 21, 1988)
  • K771588 — PLATELET CONTROLS NORMAL & ABNORMAL (August 25, 1977)
  • K770655 — LATELET DETERMIBATION KIT, UL 800 (June 24, 1977)