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510(k) K934588

CHLORIDE (MF) ASSAY by Diagnostic Chemicals , Ltd. — Product Code CHG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 18, 1994
Date Received
September 23, 1993
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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Other clearances for product code CHG

  • K941807 — INTERSECT SYSTEMS' NON-MERCURIC CHLORIDE REAGENT (September 14, 1994)
  • K903103 — SYNERMED CHLORIDE REAGENT KIT (August 9, 1990)