LEADCARE II BLOOD LEAD TESTING SYSTEM

Lead, Atomic Absorption

ESA BIOSCIENCES INC.

The following data is part of a premarket notification filed by Esa Biosciences Inc. with the FDA for Leadcare Ii Blood Lead Testing System.

Pre-market Notification Details

Device IDK052549
510k NumberK052549
Device Name:LEADCARE II BLOOD LEAD TESTING SYSTEM
ClassificationLead, Atomic Absorption
Applicant ESA BIOSCIENCES INC. 22 ALPHA RD. Chelmsford,  MA  01824 -4171
ContactHarold Asp
CorrespondentHarold Asp
ESA BIOSCIENCES INC. 22 ALPHA RD. Chelmsford,  MA  01824 -4171
Product CodeDOF  
CFR Regulation Number862.3550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-09-16
Decision Date2005-10-06
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00850355006178 K052549 000
00850355006123 K052549 000
00850355006109 K052549 000
00850355006093 K052549 000
00850355006086 K052549 000
00850355006079 K052549 000
00850355006017 K052549 000
00850355006000 K052549 000

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