ELIA CCP, MODEL 14-5515-01; ELIA CCP CONTROL, MODEL 83-1009-01

Antibodies, Anti-cyclic Citrullinated Peptide (ccp)

SWEDEN DIAGNOSTICS (US), INC.

The following data is part of a premarket notification filed by Sweden Diagnostics (us), Inc. with the FDA for Elia Ccp, Model 14-5515-01; Elia Ccp Control, Model 83-1009-01.

Pre-market Notification Details

Device IDK061165
510k NumberK061165
Device Name:ELIA CCP, MODEL 14-5515-01; ELIA CCP CONTROL, MODEL 83-1009-01
ClassificationAntibodies, Anti-cyclic Citrullinated Peptide (ccp)
Applicant SWEDEN DIAGNOSTICS (US), INC. 4169 COMMERCIAL AVE. Portage,  MI  49002
ContactMartin R Mann
CorrespondentMartin R Mann
SWEDEN DIAGNOSTICS (US), INC. 4169 COMMERCIAL AVE. Portage,  MI  49002
Product CodeNHX  
CFR Regulation Number866.5775 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-04-26
Decision Date2006-08-03
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07333066010687 K061165 000
07333066013657 K061165 000
07333066013640 K061165 000
07333066001036 K061165 000
07333066020051 K061165 000
07333066014173 K061165 000
07333066020938 K061165 000
07333066020921 K061165 000
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07333066013633 K061165 000
07333066013725 K061165 000
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07333066010649 K061165 000
07333066013893 K061165 000
07333066013848 K061165 000
07333066013800 K061165 000
07333066013756 K061165 000
07333066013749 K061165 000
07333066013732 K061165 000
07333066020907 K061165 000

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