PICCOLO(TM)

Analyzer, Chemistry, Centrifugal, For Clinical Use

ABAXIS, INC.

The following data is part of a premarket notification filed by Abaxis, Inc. with the FDA for Piccolo(tm).

Pre-market Notification Details

Device IDK942782
510k NumberK942782
Device Name:PICCOLO(TM)
ClassificationAnalyzer, Chemistry, Centrifugal, For Clinical Use
Applicant ABAXIS, INC. 1320 CHESAPEAKE TERRACE Sunnyvale,  CA  94089
ContactRodger J Richeal
CorrespondentRodger J Richeal
ABAXIS, INC. 1320 CHESAPEAKE TERRACE Sunnyvale,  CA  94089
Product CodeJJG  
Subsequent Product CodeCDN
Subsequent Product CodeCEJ
Subsequent Product CodeCEK
Subsequent Product CodeCGA
Subsequent Product CodeCGX
Subsequent Product CodeCIG
Subsequent Product CodeCIT
Subsequent Product CodeCJW
CFR Regulation Number862.2140 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-06-13
Decision Date1995-03-13

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
EABA40000331 K942782 000

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