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510(k) K970393

THYROID STIMULATING HORMONE METHOD by Dade Chemistry Systems, Inc. — Product Code JLW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 3, 1997
Date Received
February 3, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Thyroid-Stimulating Hormone
Device Class
Class II
Regulation Number
862.1690
Review Panel
CH
Submission Type

Other clearances by Dade Chemistry Systems, Inc.

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  • K973099 — PROSTATE SPECIFIC ANTIGEN CONTROL (September 29, 1997)
  • K973101 — PROSTATE SPECIFIC ANTIGEN METHOD (September 18, 1997)
  • K971141 — FT4 METHOD FOR THE DIMENSION RXL CLINICAL CHEMISTRY SYSTEM (April 28, 1997)
  • K970387 — HUMAN CHORIONIC GONADOTROPIN METHOD (March 10, 1997)
  • K970336 — MMB CALIBRATOR (March 3, 1997)
  • K970396 — HUMAN CHORIONIC GONADOTROPIN CALIBRATOR (February 20, 1997)
  • K970389 — THYROID CALIBRATOR (February 18, 1997)
  • K970343 — MMB METHOD (February 14, 1997)

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