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510(k) K953395

SYNERMED CALCIUM REAGENT KIT by Synermed, Inc. — Product Code CJY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 31, 1995
Date Received
July 18, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Azo Dye, Calcium
Device Class
Class II
Regulation Number
862.1145
Review Panel
CH
Submission Type

Other clearances by Synermed, Inc.

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  • K972716 — SYNERMED TOTAL BILIRUBIN REAGENT KIT (August 7, 1997)
  • K971491 — SYNERMED IR 200 CHEMISTRY ANALYZER (June 26, 1997)
  • K962479 — SYNERMED ISE REAGENTS (March 3, 1997)
  • K963939 — SYNERMED DIRECT BILIRUBIN REAGENT KIT (December 18, 1996)
  • K960793 — SYNERMED ENZYMATIC CO2 REAGENT KIT (March 11, 1996)
  • K952179 — SYNERMED ISE REAGENTS (June 20, 1995)
  • K943924 — CREATININE-PO REAGENT KIT (September 20, 1994)
  • K941091 — SYNERMED AMYLASE REAGENT KIT (May 3, 1994)
  • K935662 — SYNERMED IR 500 CHEMISTRY ANALYZER (April 26, 1994)

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