LIPID CONTROLS; MULTI- ANALYTE CONTROL; MULTI-ANALYTE CALIBRATION VERIFICATION MATERIALS

Multi-analyte Controls, All Kinds (assayed)

ALERE, SAN DIEGO, DBA BIOSITE INCORPORATED, DBA IN

The following data is part of a premarket notification filed by Alere, San Diego, Dba Biosite Incorporated, Dba In with the FDA for Lipid Controls; Multi- Analyte Control; Multi-analyte Calibration Verification Materials.

Pre-market Notification Details

Device IDK102700
510k NumberK102700
Device Name:LIPID CONTROLS; MULTI- ANALYTE CONTROL; MULTI-ANALYTE CALIBRATION VERIFICATION MATERIALS
ClassificationMulti-analyte Controls, All Kinds (assayed)
Applicant ALERE, SAN DIEGO, DBA BIOSITE INCORPORATED, DBA IN 9975 Summers Ridge Road San Diego,  CA  92121
ContactEdward Brehm
CorrespondentEdward Brehm
ALERE, SAN DIEGO, DBA BIOSITE INCORPORATED, DBA IN 9975 Summers Ridge Road San Diego,  CA  92121
Product CodeJJY  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-09-20
Decision Date2010-12-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00893038002845 K102700 000
00893038002210 K102700 000
00893038002036 K102700 000
00893038002029 K102700 000
00893038002012 K102700 000

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