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510(k) K970387

HUMAN CHORIONIC GONADOTROPIN METHOD by Dade Chemistry Systems, Inc. — Product Code DHA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 10, 1997
Date Received
February 3, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Human Chorionic Gonadotropin
Device Class
Class II
Regulation Number
862.1155
Review Panel
CH
Submission Type

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  • K971141 — FT4 METHOD FOR THE DIMENSION RXL CLINICAL CHEMISTRY SYSTEM (April 28, 1997)
  • K970393 — THYROID STIMULATING HORMONE METHOD (March 3, 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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