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FDA 510(k)

N ANTISERA TO HUMAN ALPHA2-MACROGLOBULIN

K-Number: K053073 · 2006-03-28

ApplicantDade Behring, Inc.
Decision Date2006-03-28
Product CodeDEB
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

N ANTISERA TO HUMAN ALPHA2-MACROGLOBULIN is the device name listed in this FDA 510(k) record. The listed applicant is Dade Behring, Inc.. It received FDA 510(k) clearance on 2006-03-28 under 510(k) number K053073. The device is classified under product code DEB. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the N ANTISERA TO HUMAN ALPHA2-MACROGLOBULIN?

N ANTISERA TO HUMAN ALPHA2-MACROGLOBULIN is a medical device that received FDA 510(k) clearance on 2006-03-28. The listed applicant is Dade Behring, Inc.. The 510(k) number is K053073.

When did N ANTISERA TO HUMAN ALPHA2-MACROGLOBULIN receive FDA 510(k) clearance?

N ANTISERA TO HUMAN ALPHA2-MACROGLOBULIN received FDA 510(k) clearance on 2006-03-28, under 510(k) number K053073.

Who is the listed applicant for N ANTISERA TO HUMAN ALPHA2-MACROGLOBULIN?

The FDA 510(k) record lists Dade Behring, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for N ANTISERA TO HUMAN ALPHA2-MACROGLOBULIN?

The FDA product code for N ANTISERA TO HUMAN ALPHA2-MACROGLOBULIN is DEB.

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Related Devices (Code: DEB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K081249DIMENSION VISTA SYSTEM A2MAC FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, DIMENSION VISTA SYSYEMDade Behring, Inc.K974564IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-2-MACROGLOBULIN REAGENTBeckman Instruments, Inc.K914389ALPHA-2 MACROGLOBULIN TEST RID KITThe Binding Site, Ltd.K896483QM300 ALPHA2 MACROGLOBULIN ANTIBODY PACKKallestad Diag, A Div. of Erbamont, Inc.K85068372 DETERM. SIZE RADIAL IMMUNODIFFUSION TEST ALPHA2Kent Laboratories, Inc.K851282RADIAL IMMUNODIFFUSION PLATES ALPHA-2 MACROGLOBULICooper Biomedical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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