QUANITITATE GBCC VERIFIER SET

Multi-analyte Controls, All Kinds (assayed)

BECKMAN INSTRUMENTS, INC.

The following data is part of a premarket notification filed by Beckman Instruments, Inc. with the FDA for Quanititate Gbcc Verifier Set.

Pre-market Notification Details

Device IDK944454
510k NumberK944454
Device Name:QUANITITATE GBCC VERIFIER SET
ClassificationMulti-analyte Controls, All Kinds (assayed)
Applicant BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD. BOX 8000 Brea,  CA  92821 -6208
ContactDon W Hart
CorrespondentDon W Hart
BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD. BOX 8000 Brea,  CA  92821 -6208
Product CodeJJY  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-09-12
Decision Date1995-01-17

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