Home / 510(k) Clearances / K945212

510(k) K945212

MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD4, CLONE MT310, FITC-CONJUGATED, (ANTI-CD4/FITC, MT310) RPE-CONJUGATED, (ANTI-CD4/ by Dako Corp. — Product Code GKZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 1996
Date Received
October 25, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Counter, Differential Cell
Device Class
Class II
Regulation Number
864.5220
Review Panel
HE
Submission Type

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  • K993957 — DAKO MONOCLONAL MOUSE ANTI-HUMAN ESTROGEN RECEPTOR (March 3, 2000)
  • K991454 — MOUSE IGG1 NEGATIVE CONTROLS (June 21, 1999)
  • K991402 — DAKO MOUSE ANTI-HUMAN T-CELL, CD3/RPE-CY5, CLONE UCHT1 & DAKO MOUSE ANTI-HUMAN T (June 21, 1999)
  • K980635 — DAKO MOUSE ANTI-HUMAN B-CELL, CD19/RPE-CY5, CLONE HD37 (July 22, 1998)
  • K971905 — DAKO MOUSE ANTI HUMAN CYTOKERATIN, HIGH MOLECULAR WEIGHT, CLONE 34BE12, MONOCLON (December 12, 1997)
  • K965022 — MONOCLONAL MOUSE ANTI-HUMAN CD30, KI-1 ANTIGEN, BER-H2 ANTIBODY FOR IMMUNOENZYMA (November 6, 1997)
  • K964974 — MOUSE ANTI-HUMAN CD45, LEUCOCYTE COMMON ANTIGEN (LCA)/FITC AND CD14, MONOCYTE/RP (June 24, 1997)

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