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510(k) K772337

URINARY 17-KETOSTERIOD/17 by Eppendorf-Brinkmann, Inc. — Product Code CDG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 12, 1978
Date Received
December 22, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Chromatography Separation/Zimmerman 17-Ketogenic Steroids
Device Class
Class I
Regulation Number
862.1385
Review Panel
CH
Submission Type

Other clearances by Eppendorf-Brinkmann, Inc.

  • K780819 — GLYCOHEMOGLOBIN-SKREEN TEST KIT (November 7, 1978)
  • K772151 — URINARY VMA - SCREEN TEST KIT (November 30, 1977)
  • K761271 — URIN. L7-OH CORTICOSTEROID T(NON HYDRO) (February 14, 1977)