QUANTITATE ELECTROLYTE VERIFIER SET (URINE RANGE)

Multi-analyte Controls, All Kinds (assayed)

BECKMAN INSTRUMENTS, INC.

The following data is part of a premarket notification filed by Beckman Instruments, Inc. with the FDA for Quantitate Electrolyte Verifier Set (urine Range).

Pre-market Notification Details

Device IDK944452
510k NumberK944452
Device Name:QUANTITATE ELECTROLYTE VERIFIER SET (URINE RANGE)
ClassificationMulti-analyte Controls, All Kinds (assayed)
Applicant BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD. BOX 8000 Brea,  CA  92821 -6208
ContactDon W Hart
CorrespondentDon W Hart
BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD. BOX 8000 Brea,  CA  92821 -6208
Product CodeJJY  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-09-12
Decision Date1994-12-02

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