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510(k) K973099

PROSTATE SPECIFIC ANTIGEN CONTROL by Dade Chemistry Systems, Inc. — Product Code JJX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 1997
Date Received
August 19, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Single (Specified) Analyte Controls (Assayed And Unassayed)
Device Class
Class I
Regulation Number
862.1660
Review Panel
CH
Submission Type

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  • K970387 — HUMAN CHORIONIC GONADOTROPIN METHOD (March 10, 1997)
  • K970336 — MMB CALIBRATOR (March 3, 1997)
  • K970393 — THYROID STIMULATING HORMONE METHOD (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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