BECKMAN DIATRAC HEMOGLOB A1C ELECTRO KIT, MODIFIED

Assay, Glycosylated Hemoglobin

BECKMAN INSTRUMENTS, INC.

The following data is part of a premarket notification filed by Beckman Instruments, Inc. with the FDA for Beckman Diatrac Hemoglob A1c Electro Kit, Modified.

Pre-market Notification Details

Device IDK925204
510k NumberK925204
Device Name:BECKMAN DIATRAC HEMOGLOB A1C ELECTRO KIT, MODIFIED
ClassificationAssay, Glycosylated Hemoglobin
Applicant BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD., W-337 BOX 8000 Brea,  CA  92622 -8000
ContactWilliam T Ryan
CorrespondentWilliam T Ryan
BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD., W-337 BOX 8000 Brea,  CA  92622 -8000
Product CodeLCP  
CFR Regulation Number864.7470 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-10-06
Decision Date1993-01-12

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