BECKMAN CX AMMONIA/ALCOHOL CONTROL

Alcohol Control Materials

BECKMAN-DIAGNOSTIC SYSTEMS GROUP

The following data is part of a premarket notification filed by Beckman-diagnostic Systems Group with the FDA for Beckman Cx Ammonia/alcohol Control.

Pre-market Notification Details

Device IDK934467
510k NumberK934467
Device Name:BECKMAN CX AMMONIA/ALCOHOL CONTROL
ClassificationAlcohol Control Materials
Applicant BECKMAN-DIAGNOSTIC SYSTEMS GROUP 200 SOUTH KRAEMER BLVD. Brea,  CA  92621 -6209
ContactWilliam T Ryan
CorrespondentWilliam T Ryan
BECKMAN-DIAGNOSTIC SYSTEMS GROUP 200 SOUTH KRAEMER BLVD. Brea,  CA  92621 -6209
Product CodeDKC  
CFR Regulation Number862.3280 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-09-10
Decision Date1993-10-27

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
15099590222734 K934467 000
15099590222727 K934467 000
15099590222710 K934467 000

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