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510(k) K940570

SYNERMED TOTAL BILIRUBIN REAGENT KIT by Synermed, Inc. — Product Code CIG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 20, 1994
Date Received
February 8, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Diazo Colorimetry, Bilirubin
Device Class
Class II
Regulation Number
862.1110
Review Panel
CH
Submission Type

Other clearances by Synermed, Inc.

  • K973109 — SYNERMED NEAR-INFRARED DIRECT BILIRUBIN REAGENT KIT (September 25, 1997)
  • 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)
  • K953395 — SYNERMED CALCIUM REAGENT KIT (August 31, 1995)
  • K952179 — SYNERMED ISE REAGENTS (June 20, 1995)
  • K943924 — CREATININE-PO REAGENT KIT (September 20, 1994)
  • K941091 — SYNERMED AMYLASE REAGENT KIT (May 3, 1994)

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  • K171401 — ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN (July 11, 2017)
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