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FDA 510(k)

HUMAN ALPHA2 MACROGLOBULIN

K-Number: K791340 · 1979-08-16

ApplicantBeckman Instruments, Inc.
Decision Date1979-08-16
Product CodeDEB
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

HUMAN ALPHA2 MACROGLOBULIN is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Instruments, Inc.. It received FDA 510(k) clearance on 1979-08-16 under 510(k) number K791340. 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 HUMAN ALPHA2 MACROGLOBULIN?

HUMAN ALPHA2 MACROGLOBULIN is a medical device that received FDA 510(k) clearance on 1979-08-16. The listed applicant is Beckman Instruments, Inc.. The 510(k) number is K791340.

When did HUMAN ALPHA2 MACROGLOBULIN receive FDA 510(k) clearance?

HUMAN ALPHA2 MACROGLOBULIN received FDA 510(k) clearance on 1979-08-16, under 510(k) number K791340.

Who is the listed applicant for HUMAN ALPHA2 MACROGLOBULIN?

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

What is the FDA product code for HUMAN ALPHA2 MACROGLOBULIN?

The FDA product code for HUMAN ALPHA2 MACROGLOBULIN is DEB.

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Other records listing Beckman Instruments, Inc. as applicant

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.

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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.K053073N ANTISERA TO HUMAN ALPHA2-MACROGLOBULINDade 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.

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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