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510(k) Data Aggregation

K Number

Device Name

GLYCACOR

Manufacturer

Date Cleared

1998-08-13

(157 days)

Product Code

Regulation Number

Why did this record match?

Applicant Name (Manufacturer) :

EXOCELL, INC.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty

Intended Use

Enzyme linked Immunosorbent Assay (ELISA), non-radioactive, for determination of glycated LDL (low-density lipoprotein) in plasma

Device Description

Not Found

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