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510(k) K946335

OPTICLONE(TM CD3 FITC/CD19 PE MONOCLONAL ANTIBODIES by Immunotech, Inc. — Product Code GKZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 1995
Date Received
December 29, 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

Other clearances by Immunotech, Inc.

  • K954188 — OPTICLONE IGG1 FITC/IGG2A PE ISOTYPIC CONTROL (November 3, 1995)
  • K953498 — OPTICLONE IGG1 FITC/IGG1 PE ISOTYPIC CONTROL (September 8, 1995)
  • K952789 — OPTICLONE CD4FITC/CD8 PE MONOCLONAL ANTIBODIES (August 14, 1995)
  • K952182 — OPTICLONE CD3/CD8 MONOCLONAL ANTIBODIES (July 5, 1995)
  • K950626 — OPTICLONE CD3/CD4 MONOCLONAL ANTIBODIES (May 5, 1995)
  • K934012 — FT4 RADIOIMMUNOASSAY (November 16, 1993)
  • K931228 — PROGESTERONE RADIOIMMUNOASSAY KIT (October 22, 1993)
  • K911634 — MICROZYME(TM) FREE T4 ENZYME IMMUNOASSAY TEST (June 24, 1991)
  • K911153 — MICROZYME PHENCYCLIDINE ENZYME IMMUNOASSAY TEST KT (June 18, 1991)
  • K910411 — MICROZYME TSH ENZYME IMMUNOASSAY KIT (April 3, 1991)

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