APOLIPOPROTEIN CALIBRATOR (APO-CAL)

Calibrator, Multi-analyte Mixture

BECKMAN INSTRUMENTS, INC.

The following data is part of a premarket notification filed by Beckman Instruments, Inc. with the FDA for Apolipoprotein Calibrator (apo-cal).

Pre-market Notification Details

Device IDK953979
510k NumberK953979
Device Name:APOLIPOPROTEIN CALIBRATOR (APO-CAL)
ClassificationCalibrator, Multi-analyte Mixture
Applicant BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD., W-337 BOX 8000 Brea,  CA  92622 -8000
ContactDon W Hart
CorrespondentDon W Hart
BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD., W-337 BOX 8000 Brea,  CA  92622 -8000
Product CodeJIX  
CFR Regulation Number862.1150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-08-23
Decision Date1995-10-03

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
15099590232023 K953979 000

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