IMMAGE IMMUNOCHEMISTRY SYSTEM VALPROIC ACID (VPA) REAGENT

Calibrators, Drug Mixture

BECKMAN INSTRUMENTS, INC.

The following data is part of a premarket notification filed by Beckman Instruments, Inc. with the FDA for Immage Immunochemistry System Valproic Acid (vpa) Reagent.

Pre-market Notification Details

Device IDK981403
510k NumberK981403
Device Name:IMMAGE IMMUNOCHEMISTRY SYSTEM VALPROIC ACID (VPA) REAGENT
ClassificationCalibrators, Drug Mixture
Applicant BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD., W-104 Brea,  CA  92621
ContactAnnette Hellie
CorrespondentAnnette Hellie
BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD., W-104 Brea,  CA  92621
Product CodeDKB  
CFR Regulation Number862.3200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-04-17
Decision Date1998-05-08
Summary:summary

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