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510(k) K911153

MICROZYME PHENCYCLIDINE ENZYME IMMUNOASSAY TEST KT by Immunotech Corp. — Product Code LCM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 18, 1991
Date Received
March 15, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Phencyclidine
Device Class
Class U
Regulation Number
Review Panel
TX
Submission Type

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  • 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)
  • K910411 — MICROZYME TSH ENZYME IMMUNOASSAY KIT (April 3, 1991)

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