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510(k) K934271

BECKMAN SYNCHRON LACTATE REAGENT by Beckman-Diagnostic Systems Group — Product Code KHP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 9, 1993
Date Received
August 31, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Acid, Lactic, Enzymatic Method
Device Class
Class I
Regulation Number
862.1450
Review Panel
CH
Submission Type

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  • K936184 — VIGIL PRX CHEMISTRY CONTROL (April 15, 1994)
  • K934046 — BECKMAN CHOLESTEROL REAGENT (October 28, 1993)
  • K934467 — BECKMAN CX AMMONIA/ALCOHOL CONTROL (October 27, 1993)

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