SYNCHRON CX SYSTEMS LIPASE (LIPA) REAGENT

Lipase-esterase, Enzymatic, Photometric, Lipase

BECKMAN INSTRUMENTS, INC.

The following data is part of a premarket notification filed by Beckman Instruments, Inc. with the FDA for Synchron Cx Systems Lipase (lipa) Reagent.

Pre-market Notification Details

Device IDK970905
510k NumberK970905
Device Name:SYNCHRON CX SYSTEMS LIPASE (LIPA) REAGENT
ClassificationLipase-esterase, Enzymatic, Photometric, Lipase
Applicant BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD. M.S. W-351 Brea,  CA  92621
ContactSheri Hall
CorrespondentSheri Hall
BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD. M.S. W-351 Brea,  CA  92621
Product CodeCHI  
CFR Regulation Number862.1465 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-03-12
Decision Date1997-06-04
Summary:summary

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