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510(k) K870369

CALCIUM REAGENT-METHYL THYMOL BLUE METHOD by Trace Scientific , Ltd. — Product Code CIA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 19, 1987
Date Received
January 28, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Methylthymol Blue, Calcium
Device Class
Class II
Regulation Number
862.1145
Review Panel
CH
Submission Type

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  • K952488 — TRACE COBAS MIRA RANGE (October 13, 1995)
  • K932713 — TRACE TRANSFERRIN REAGENT (September 30, 1993)
  • K923322 — TRACE ALBUMIN-MR REAGENT (September 11, 1992)
  • K914731 — TRACE GAMMA GT-SS REAGENT (November 19, 1991)
  • K911866 — TRACE TOTAL/DIRECT BILIRUBIN REAGENT (July 17, 1991)

Other clearances for product code CIA

  • K863059 — CALCIOMETER (September 26, 1986)
  • K822898 — DSL 1600 (December 9, 1982)
  • K792396 — ELVI CALCIUM (December 6, 1979)
  • K771468 — MULTISTAT III CALCIUM TEST (September 12, 1977)