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510(k) K903103

SYNERMED CHLORIDE REAGENT KIT by Synermed, Inc. — Product Code CHG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 9, 1990
Date Received
July 13, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Acid, Phosphoric-Tungstic (Spectrophotometric), Chloride
Device Class
Class II
Regulation Number
862.1170
Review Panel
CH
Submission Type

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  • K952179 — SYNERMED ISE REAGENTS (June 20, 1995)
  • K943924 — CREATININE-PO REAGENT KIT (September 20, 1994)
  • K941091 — SYNERMED AMYLASE REAGENT KIT (May 3, 1994)

Other clearances for product code CHG

  • K941807 — INTERSECT SYSTEMS' NON-MERCURIC CHLORIDE REAGENT (September 14, 1994)
  • K934588 — CHLORIDE (MF) ASSAY (February 18, 1994)